Atopic DermatitisPhase 2NCT03100344
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
A Phase 2 study testing Nemolizumab in people with Atopic Dermatitis, run by Galderma R&D at 67 sites in 6 countries.
Trial summary
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 67 sitesin 6 countries
- Study dates
- 14 Jun 2017to 21 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 18 years (or legal age when higher)
- Chronic AD, that has been present for at least 2 years before the visit
- Eczema Area and Severity Index (EASI) score ≥12
- Investigator Global Assessment (IGA) score ≥ 3
- AD involvement ≥ 10% of Body Surface Area (BSA)
- Severe pruritus on at least 3 of the last 7 days before the visit
Show all 10Show fewer
- Documented recent history (within 6 months before the visit) of inadequate response to topical medications
- Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential
- Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration
Who cannot join
- Body weight < 45 kg
- subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
- Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
- History of intolerance to low or mid potency TCS or for whom TCS is not advisable
Trial locations and contacts
67 sites in 6 countries.
67 sites in 6 countries
United States26 sites
Galderma Investigational site
Beverly Hills, California, 90212
Galderma Investigational site
Birmingham, Alabama, 35209
Galderma Investigational site
Chapel Hill, North Carolina, 27516
Galderma Investigational site
Columbus, Georgia, 31904
Galderma Investigational site
Dallas, Texas, 75230
Galderma Investigational Site
Darien, Illinois, 60561
Galderma Investigational Site
Farmington Hills, Michigan, 78334
Galderma Investigational site
Forest Hills, New York, 11375
Galderma Investigational site
Fort Smith, Arkansas, 72916
Galderma Investigational site
Fountain Valley, California, 92708
Galderma Investigational site
Fremont, California, 94538
Galderma Investigational Site
Johnston, Rhode Island, 02919
Galderma Investigational site
Miami, Florida, 33135
Galderma Investigational site
New Orleans, Louisiana, 70115
Galderma Investigational site
New York, New York, 10025
Galderma Investigational Site
New York, New York, 10075
Galderma Investigational Site
Overland Park, Kansas, 66215
Galderma Investigational site
Richmond, Virginia, 23220
Galderma Investigational site
Rolling Hills Estates, California, 90274
Galderma Investigational site
San Antonio, Texas, 78218
Galderma Investigational site
Sandy Springs, Georgia, 30328
Galderma Investigational site
Santa Ana, California, 92701
Galderma Investigational site
Santa Monica, California, 90404
Galderma Investigational site
Tampa, Florida, 33607
Galderma Investigational Site
Tampa, Florida, 33624
Galderma Investigational Site
Waco, Texas, 76710
Germany13 sites
Galderma Investigational Site
Berlin, 10117
Galderma Investigational Site
Berlin, 10789
Galderma Investigational Site
Darmstadt, 64283
Galderma Investigational Site
Erlangen, 91054
Galderma Investigational Site
Frankfurt, 60590
Galderma Investigational Site
Hamburg, 20354
Galderma Investigational Site
Hannover, 30625
Galderma Investigational Site
Heidelberg, 69120
Galderma Investigational Site
Langenau, 89129
Galderma Investigational Site
Mainz, 55131
Galderma Investigational Site
München, 80337
Galderma Investigational Site
Osnabrück, 49074
Galderma Investigational Site
Stuttgart, 70718
Canada9 sites
Galderma Investigational Site
Calgary, AB T3A 2N1
Galderma Investigational Site
Markham, ON L3P 1X2
Galderma Investigational Site
Oakville, ON L6J 7W5
Galderma Investigational Site
Ottawa, K1G 6C6
Galderma Investigational Site
Ottawa, ON K2G 6E2
Galderma Investigational Site
Peterborough, K9J
Galderma Investigational Site
Richmond Hill, ON L4C
Galderma Investigational Site
Sainte-Foy, QC G1V4X7
Galderma Investigational Site
Waterloo, ON N2J 1C4
Poland9 sites
Galderma Investigational Site
Katowice, 40-123
Galderma Investigational Site
Katowice, 40-648
Galderma Investigational Site
Krakow, 31-024
Galderma Investigational Site
Lodz, 90-436
Galderma Investigational Site
Lublin, 20-080
Galderma Investigational Site
Warsaw, 01-817
Galderma Investigational Site
Warsaw, 02-625
Galderma Investigational Site
Warsaw, 02-758
Galderma Investigational Site
Wroclaw, 51-318
France6 sites
Galderma Investigational Site
Bordeaux, 33075
Galderma Investigational Site
Lille, 59037
Galderma Investigational Site
Marseille, 13385
Galderma Investigational Site
Nice, 06202
Galderma Investigational Site
Paris, 75010
Galderma Investigational Site
Toulouse, 31059
Australia4 sites
Galderma Investigational Site
Benowa, 4217 QLD
Galderma Investigational Site
Kogarah, NSW 2217
Galderma Investigational Site
Melbourne, VIC3002
Galderma Investigational Site
Phillip, ACT2606
About this study
Official title: Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.
Read the detailed description
The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.
- Conditions
- Atopic Dermatitis
- Being tested
- Nemolizumab, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemolizumabDrug
Injection every 4 weeks during 24 weeks (last injection at week 20)
PlaceboDrug
Injection every 4 weeks during 24 weeks (last injection at week 20)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Nemolizumab (low dose) Receives: Drug: Nemolizumab |
| Group 2 | Experimental | Nemolizumab (medium dose) Receives: Drug: Nemolizumab |
| Group 3 | Experimental | Nemolizumab (high dose) Receives: Drug: Nemolizumab |
| Group 4 | Placebo comparator | Nemolizumab placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
Measured: From Baseline to Week 24
Secondary outcomes (17)
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.
Measured: Week 24
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Measured: From Week 1 to Week 24
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
Measured: Baseline, Week 24
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
Measured: Baseline, Week 24
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Measured: Baseline, Week 24
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Measured: Baseline, Week 24
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
Measured: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
Measured: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
Measured: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
Measured: From Week 1 to Week 24
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24
IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
Measured: Week 1 to Week 24
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
Measured: From Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Measured: At baseline and Week 24
Number of Participants With Adverse Events
To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
Measured: From screening to Follow-up visit (Week 32)/Early termination visit
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Measured: Baseline to Week 24
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Measured: Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start14 Jun 2017
- Primary completion19 Jul 2018
- Study completion21 Sep 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100344
- Sponsor's protocol ID
- RD.03.SPR.114322
- Status last verified
- Oct 2019
- First submitted
- 29 Mar 2017
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dias-Barbosa C, Silverberg JI, Stander S, Rodriguez D, Fofana F, Filipenko D, Ulianov L, Piketty C, Puelles J. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024 Jul 15;8(1):73. doi: 10.1186/s41687-024-00751-7.
PubMed 39008191Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.
PubMed 31449914
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)
- ClinicalTrials.gov ID
- NCT03100344
- Acronym / sponsor ID
- RD.03.SPR.114322
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.
Detailed description
The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: NemolizumabNemolizumab (low dose) |
| Group 2 | Experimental | Drug: NemolizumabNemolizumab (medium dose) |
| Group 3 | Experimental | Drug: NemolizumabNemolizumab (high dose) |
| Group 4 | Placebo comparator | Drug: PlaceboNemolizumab placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects ≥ 18 years (or legal age when higher)
- Chronic AD, that has been present for at least 2 years before the visit
- Eczema Area and Severity Index (EASI) score ≥12
- Investigator Global Assessment (IGA) score ≥ 3
- AD involvement ≥ 10% of Body Surface Area (BSA)
Key exclusion criteria (5 listed)
- Body weight < 45 kg
- subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
- Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
- History of intolerance to low or mid potency TCS or for whom TCS is not advisable
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 |
|---|---|---|
| NemolizumabInjection every 4 weeks during 24 weeks (last injection at week 20) | Drug | Group 1, Group 2, Group 3 |
| PlaceboInjection every 4 weeks during 24 weeks (last injection at week 20) | Drug | Group 4 |
Primary outcome
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
Time frame: From Baseline to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
17 secondary outcomes
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
Time frame: Week 24
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
Time frame: From Week 1 to Week 24
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Time frame: Baseline, Week 24
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Time frame: Baseline, Week 24
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Time frame: Baseline, Week 24
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
Time frame: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time frame: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time frame: From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time frame: From Week 1 to Week 24
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24
Time frame: Week 1 to Week 24
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
Time frame: From Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time frame: At baseline and Week 24
Number of Participants With Adverse Events
Time frame: From screening to Follow-up visit (Week 32)/Early termination visit
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time frame: Baseline to Week 24
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time frame: Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39008191Dias-Barbosa C, Silverberg JI, Stander S, Rodriguez D, Fofana F, Filipenko D, Ulianov L, Piketty C, Puelles J. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024 Jul 15;8(1):73. doi: 10.1186/s41687-024-00751-7.
- Derived from this study: PubMed 31449914Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.
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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.
67 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nemolizumab in people with Atopic Dermatitis, run by Galderma R&D at 67 sites in 6 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 10 inclusion and 5 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Germany, Canada, Poland, France and 1 more country. 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 22 Oct 2019). 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?
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 (time frame: From Baseline to Week 24). 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 NCT03100344, which also lists 2 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 22 Oct 2019.