EczemaPhase 2STREAM-ADNCT05131477
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
A Phase 2 study testing Amlitelimab in people with Eczema and Atopic Dermatitis, run by Kymab Limited at 103 sites in 12 countries.
Trial summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eczema, Atopic Dermatitis
- What is being tested?
- Amlitelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 103 sitesin 12 countries
- Study dates
- 13 Dec 2021to 21 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
- Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
- AD involvement of 10% or more of body surface area (BSA) at Baseline.
- Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of ≥4.
- Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.
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- Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
- Able to complete patient questionnaires.
- Able and willing to comply with requested study visits/telephone visits and procedures.
- Able and willing to provide written informed consent.
- For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.
Who cannot join
- Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
- Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Weight <40 kg or >150 kg at Baseline.
- Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
- Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
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- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
- Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
- In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit.
- Concurrent participation in any other clinical study, including non-interventional studies.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
103 sites in 12 countries.
103 sites in 12 countries
Poland22 sites
Investigative site #2419
Bialystok, Podlaskie Voivodeship, 15-879
Investigative site #2419
Bialystok, 15-879
Investigative Site Number: 2402
Gdansk, Pomeranian Voivodeship, 80-382
Investigative Site Number: 2403
Gdansk, 80-592
Investigative Site Number: 2404
Gdynia, Pomeranian Voivodeship, 81-384
Investigative Site Number: 2405
Katowice, Silesian Voivodeship, 40-040
Investigative Site Number: 2408
Krakow, Lesser Poland Voivodeship, 30-033
Investigative Site Number: 2407
Krakow, Lesser Poland Voivodeship, 30-510
Investigative Site Number: 2409
Krakow, Lesser Poland Voivodeship, 31-011
Investigative Site Number: 2406
Krakow, 31-559
Investigative Site Number: 2420
Lodz, Lódzkie, 90-349
Investigative site #2420
Lodz, 90-349
Investigative Site Number: 2416
Lodz, Łódź Voivodeship, 90-436
Investigative Site Number: 2415
Lódz, Lódzkie, 90-127
Investigative Site Number: 2401
Rzeszów, Podkarpackie Voivodeship, 35-055
Investigative Site Number: 2410
Szczecin, West Pomeranian Voivodeship, 71-434
Investigative Site Number: 2412
Warsaw, Masovian Voivodeship, 00-874
Investigative Site Number: 2411
Warsaw, Masovian Voivodeship, 01-142
Investigative Site Number: 2413
Warsaw, Masovian Voivodeship, 01-192
Investigative Site Number: 2414
Wroclaw, Lower Silesian Voivodeship, 50-088
Investigative Site Number: 2418
Wroclaw, Lower Silesian Voivodeship, 50-368
Investigative Site Number: 2417
Wroclaw, Lower Silesian Voivodeship, 51-685
United States20 sites
Investigative Site Number: 1003
Anderson, South Carolina, 29621-2062
Investigative Site Number: 1014
Beverly, Massachusetts, 01915-1666
Investigative Site Number: 1006
Boca Raton, Florida, 33428
Investigative Site Number: 1010
Clarksville, Indiana, 47129-2201
Investigative Site Number: 1001
Clearwater, Florida, 33756-3424
Investigative Site Number: 1019
Coral Gables, Florida, 33134-2950
Investigative Site Number: 1018
Fremont, California, 94538-1601
Investigative Site Number: 1015
Indianapolis, Indiana, 46250-2041
Investigative Site Number: 1021
Louisville, Kentucky, 40241
Investigative site #1023
Mansfield, Texas, 76063
Investigative Site Number: 1007
Miami, Florida, 33176-2264
Investigative Site Number: 1008
Murfreesboro, Tennessee, 37130-2450
Investigative Site Number: 1017
Portland, Oregon, 97223-6683
Investigative Site Number: 1009
Portland, Oregon, 97239
Investigative site #1022
Sacramento, California, 95816-3370
Investigative Site Number: 1004
Savannah, Georgia, 31406-2668
Investigative Site Number: 1013
Tampa, Florida, 33615-3816
Investigative Site Number: 1011
Towson, Maryland, 21204-7448
Investigative Site Number: 1012
Troy, Michigan, 48084-3536
Investigative Site Number: 1005
Tulsa, Oklahoma, 74136-7049
Japan15 sites
Investigative Site Number: 3112
Adachi-Ku, Tokyo, 120-0034
Investigative Site Number: 3115
Chuo Ku, Tokyo
Investigative Site Number: 3104
Edagowa-Ku, Tokyo, 133-0052
Investigative Site Number: 3109
Habikino-Shi, Ôsaka, 583-0872
Investigative site #3108
Kagoshima, Kagoshima-ken, 890-0063
Investigative Site Number: 3111
Koto-Ku, Tokyo, 136-0074
Investigative site #3102
Kyoto, 602-0841
Investigative Site Number: 3103
Matsudo, Chiba, 270-2223
Investigative Site Number: 3106
Mibu-machi, 321-0293
Investigative Site Number: 3107
Minato-Ku, Tokyo, 108-0014
Investigative Site Number: 3114
Obihiro-Shi, Hokkaidô, 080-0013
Investigative Site Number: 3110
Sakaishi, Ôsaka, 593-8324
Investigative site #3101
Sapporo, 060-0063
Investigative site #3105
Setagaya-Ku, Tokyo, 158-0097
Investigative site #3113
Yokohama, Kanagawa, 221-0825
Hungary7 sites
Investigative Site Number: 2304
Budapest, 1036
Investigative Site Number: 2303
Debrecen, Hajdú-Bihar, 4032
Investigative Site Number: 2305
Gyula, Bekes County, 5700
Investigative Site Number: 2307
Kecskemét, Bács-Kiskun county, 6000
Investigative Site Number: 2301
Szeged, Csongrád megye, 6720
Investigative Site Number: 2306
Szolnok, Jász-Nagykun-Szolnok, 5000
Investigative Site Number: 2302
Zalaegerszeg, Zala County, 8900
Bulgaria6 sites
Investigative Site Number: 2004
Pleven, 5800
Investigative Site Number: 2005
Sofia, 1431
Investigative Site Number: 2006
Sofia, 1592
Investigative Site Number: 2003
Sofia, 1612
Investigative Site Number: 2002
Sofia, 1784
Investigative Site Number: 2001
Stara Zagora, 6003
Czechia6 sites
Investigative Site Number: 2108
Brno, South Moravian, 602 00
Investigative Site Number: 2106
Kutná Hora, 284 01
Investigative Site Number: 2105
Nový Jicín, Moravian-Silesian Region, 741 01
Investigative Site Number: 2104
Ostrava, 702 00
Investigative Site Number: 2102
Prague, Praha, Hlavní Mesto, 108 00
Investigative Site Number: 2103
Prague, Praha, Hlavní Mesto, 130 00
Germany6 sites
Investigative Site Number: 2203
Berlin, 10117
Investigative Site Number: 2202
Blankenfelde, Brandenburg, 15827
Investigative Site Number: 2209
Erlangen, Bavaria, 91054
Investigative Site Number: 2204
Hamburg, 20251
Investigative Site Number: 2208
Kiel, Schleswig-Holstein, 2405
Investigator Site Number: 2201
Münster, North Rhine-Westphalia, 48149
Canada5 sites
Investigative Site Number: 1106
Markham, Ontario, L3P 1X2
Investigative site #1108
Niagara Falls, Ontario, L2H 1H5
Investigative Site Number: 1103
Ottawa, Ontario, K2C 3N2
Investigative Site Number: 1107
Waterloo, Ontario, N2J 1C4
Investigative Site Number: 1101
Windsor, Ontario, N8W 1E6
Spain5 sites
Investigative Site Number: 2505
Alicante, 3010
Investigative Site Number: 2501
Córdoba, 14004
Investigative Site Number: 2503
Madrid, 28046
Investigative Site Number: 2502
Manises, Valencia, 46940
Investigative Site Number: 2504
Pontevedra, 36001
Taiwan5 sites
Investigative Site Number: 3201
Niao Song Qu, 833
Investigative Site Number: 3202
Taichung, 402
Investigative site # 3206
Taipei, 11217
Investigative site # 3206
Taipei, 112217
Investigative Site Number: 3203
Taoyuan, 33305
Australia3 sites
Investigative Site Number 3002
Carlton, 3053
Investigative Site Number: 3003
East Melbourne, 3002
Investigational Site Number: 3001
Parkville, 3050
United Kingdom3 sites
Investigative Site Number: 2603
London, E11 1NR
Investigative Site Number: 2601
London, SE1 9RT
Investigative Site Number: 2602
Sheffield, S10 2TF
About this study
Official title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
- Conditions
- Eczema, Atopic Dermatitis
- Being tested
- Amlitelimab, Placebo
- Keywords
- KY1005, Monoclonal Antibody, Atopic Dermatitis, Atopic Eczema, OX40L
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlitelimabDrug
Also called KY1005, SAR445229, A human anti-OX40 ligand monoclonal antibody
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
PlaceboDrug
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 250mg (500mg Loading Dose) KY1005 | Experimental | Every 4 weeks Receives: Drug: Amlitelimab |
| 250mg (No Loading Dose) KY1005 | Experimental | Every 4 weeks Receives: Drug: Amlitelimab |
| 125mg KY1005 | Experimental | Every 4 weeks Receives: Drug: Amlitelimab |
| 62.5mg KY1005 | Experimental | Every 4 weeks Receives: Drug: Amlitelimab |
| Placebo | Placebo comparator | Every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to week 16
Secondary outcomes (54)
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to week 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to week 16 and week 24
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
Measured: Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 2,4, 8,12,16, 20 and 24
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Measured: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Measured: Baseline to weeks 2, 4, 8,12,16,20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Measured: Baseline to weeks 4, 8, 12, 16, 20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Measured: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Measured: Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Absolute Change in Affected BSA From Baseline (Part 2)
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Affected BSA From Baseline (Part 1)
Measured: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Percentage Change in Affected BSA From Baseline (Part 2)
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Measured: Baseline to weeks 4, 8, 12, 16, 20, & 24
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Measured: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Measured: Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Measured: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Measured: Baseline to weeks 2, 8, 16, 20, & 24
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Measured: Baseline to weeks 2, 8, 16, 20, & 24
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Measured: Baseline to weeks 16, & 24
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Measured: Baseline to weeks 24, 36 & 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Measured: Baseline to weeks 16, & 24
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Measured: Baseline to weeks 24, 36 & 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Measured: Baseline to weeks 8 16, 20, & 24
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Measured: Baseline to weeks 8, 16, 20, & 24
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Measured: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Incidence Rate of Loss of EASI 50 (Part 2)
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Measured: Week 24 to week 52
Incidence Rate of Loss of EASI 75 (Part 2)
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Measured: Week 24 to week 52
Incidence Rate of Loss of IGA 0/1 (Part 2)
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Measured: Week 24 to week 68
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Measured: Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Measured: Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Measured: Baseline through week 24
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Measured: Week 24 through week 68
Percentage of Participants With Treatment-emergent ADA (Part 1)
Measured: Baseline through week 24
Percentage of Participants With Treatment-emergent ADA (Part 2)
Measured: Baseline through week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start13 Dec 2021
- Primary completion26 Apr 2023
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131477
- Sponsor's protocol ID
- KY1005-CT05/DRI17366
- Other IDs
- 2021-000725-28, U1111-1271-1438, DRI17366
- Acronym
- STREAM-AD
- Status last verified
- Jun 2025
- First submitted
- 11 Nov 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Reich A, Blauvelt A, Weidinger S, Shi VY, Katoh N, Lynde C, Gao X, Armstrong NM, Bernigaud C, Rahawi K. A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):605-616. doi: 10.1007/s13555-025-01609-6. Epub 2025 Dec 8.
PubMed 41359216Blauvelt A, Chovatiya R, Merola JF, Weidinger S, Igawa K, Brookes E, Weber C, Wang J, Gray C. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab. J Eur Acad Dermatol Venereol. 2025 Dec;39(12):2113-2120. doi: 10.1111/jdv.20877. Epub 2025 Jul 24.
PubMed 40704660Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, Lynde C, Kataoka Y, Foley P, Wei X, Wong W, Solente AC, Weber C, Adelman S, Davey S, Hurbin F, Rynkiewicz N, Yen K, O'Malley JT, Bernigaud C. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025 Apr;155(4):1264-1275. doi: 10.1016/j.jaci.2024.10.031. Epub 2024 Nov 8.
PubMed 39522654
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05131477
- Acronym / sponsor ID
- STREAM-AD / KY1005-CT05/DRI17366
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- KY1005, Monoclonal Antibody, Atopic Dermatitis, Atopic Eczema, OX40L
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Kymab LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 250mg (500mg Loading Dose) KY1005 | Experimental | Drug: AmlitelimabEvery 4 weeks |
| 250mg (No Loading Dose) KY1005 | Experimental | Drug: AmlitelimabEvery 4 weeks |
| 125mg KY1005 | Experimental | Drug: AmlitelimabEvery 4 weeks |
| 62.5mg KY1005 | Experimental | Drug: AmlitelimabEvery 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboEvery 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
- Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
- AD involvement of 10% or more of body surface area (BSA) at Baseline.
- Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of ≥4.
Key exclusion criteria (11 listed)
- Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
- Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Weight <40 kg or >150 kg at Baseline.
- Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlitelimabAlso: KY1005, SAR445229, A human anti-OX40 ligand monoclonal antibodyPharmaceutical form: Injection solution Route of administration: Subcutaneous | Drug | 125mg KY1005, 250mg (500mg Loading Dose) KY1005, 250mg (No Loading Dose) KY1005, 62.5mg KY1005 |
| PlaceboPharmaceutical form: Injection solution Route of administration: Subcutaneous | Drug | Placebo |
Primary outcome
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Time frame: Baseline to week 16
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
54 secondary outcomes
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Time frame: Baseline to week 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Time frame: Baseline to week 16 and week 24
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
Time frame: Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
Time frame: Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Time frame: Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Time frame: Baseline to weeks 2,4, 8,12,16, 20 and 24
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Time frame: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Time frame: Baseline to weeks 2, 4, 8,12,16,20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Time frame: Baseline to weeks 4, 8, 12, 16, 20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Time frame: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Absolute Change in Affected BSA From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Affected BSA From Baseline (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Percentage Change in Affected BSA From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Time frame: Baseline to weeks 2, 8, 16, 20, & 24
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Time frame: Baseline to weeks 2, 8, 16, 20, & 24
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Time frame: Baseline to weeks 16, & 24
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 36 & 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Time frame: Baseline to weeks 16, & 24
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 36 & 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Time frame: Baseline to weeks 8 16, 20, & 24
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Time frame: Baseline to weeks 8, 16, 20, & 24
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41359216Reich A, Blauvelt A, Weidinger S, Shi VY, Katoh N, Lynde C, Gao X, Armstrong NM, Bernigaud C, Rahawi K. A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):605-616. doi: 10.1007/s13555-025-01609-6. Epub 2025 Dec 8.
- Derived from this study: PubMed 40704660Blauvelt A, Chovatiya R, Merola JF, Weidinger S, Igawa K, Brookes E, Weber C, Wang J, Gray C. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab. J Eur Acad Dermatol Venereol. 2025 Dec;39(12):2113-2120. doi: 10.1111/jdv.20877. Epub 2025 Jul 24.
- Derived from this study: PubMed 39522654Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, Lynde C, Kataoka Y, Foley P, Wei X, Wong W, Solente AC, Weber C, Adelman S, Davey S, Hurbin F, Rynkiewicz N, Yen K, O'Malley JT, Bernigaud C. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025 Apr;155(4):1264-1275. doi: 10.1016/j.jaci.2024.10.031. Epub 2024 Nov 8.
- DRI17366 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
103 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amlitelimab in people with Eczema and Atopic Dermatitis, run by Kymab Limited at 103 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in Poland, United States, Japan, Hungary, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131477, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.