Prurigo NodularisPhase 3NCT04501666
Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
A Phase 3 study testing Nemolizumab 30 mg in people with Prurigo Nodularis, run by Galderma R&D at 100 sites in 10 countries.
Trial summary
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Nemolizumab 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 100 sitesin 10 countries
- Study dates
- 11 Sep 2020to 21 Feb 2023
- Phase
- Phase 3
- 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
- Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits.
- Severe pruritus was defined as follows on the PP NRS:
- At the screening visit (Visit 1): PP NRS score was >= 7.0 for the 24-hour period immediately preceding the screening visit.
- At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was >= 7.0 over the previous week.
- Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.
Who cannot join
- Body weight less than < 30 kg.
- Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [e.g.] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
- Unilateral lesions of prurigo (e.g., only one arm affected).
- History of or current confounding skin condition (e.g., Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis).
- Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
- Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit.
- Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit.
Trial locations and contacts
100 sites in 10 countries.
100 sites in 10 countries
United States38 sites
Galderma Investigational Site
Ann Arbor, Michigan, 48109
Galderma Investigational Site
Austin, Texas, 78738
Galderma Investigational Site
Baltimore, Maryland, 21231
Galderma Investigational Site
Bellaire, Texas, 77401
Galderma Investigational Site
Birmingham, Alabama, 35233
Galderma Investigational Site
Birmingham, Alabama, 35244
Galderma Investigational Site
Chicago, Illinois, 60613
Galderma Investigational Site
Cleveland, Ohio, 44106
Galderma Investigational Site
Columbus, Georgia, 31904
Galderma Investigational Site
Delray Beach, Florida, 33484
Galderma Investigational Site
Fairfax, Virginia, 22031
Galderma Investigational Site
High Point, North Carolina, 27262
Galderma Investigational Site
Hollywood, Florida, 33021
Galderma Investigational Site
Johnston, Rhode Island, 02919
Galderma Investigational Site
Knoxville, Tennessee, 37909
Galderma Investigational Site
Lake Bluff, Illinois, 60044
Galderma Investigational Site
Laredo, Texas, 78401
Galderma Investigational Site
Largo, Florida, 33770
Galderma Investigational Site
Los Angeles, California, 90045
Galderma Investigational Site
Macon, Georgia, 31217
Galderma Investigational Site
Miami, Florida, 33125
Galderma Investigational Site
New York, New York, 10065
Galderma Investigational Site
Norman, Oklahoma, 73071
Galderma Investigational Site
Pembroke Pines, Florida, 33028
Galderma Investigational Site
Philadelphia, Pennsylvania, 19103
Galderma Investigational Site
Philadelphia, Pennsylvania, 19104
Galderma Investigational Site
Providence, Rhode Island, 02903
Galderma Investigational Site
Raleigh, North Carolina, 27617
Galderma Investigational Site
Sacramento, California, 95815
Galderma Investigational Site
Saint Joseph, Missouri, 64506
Galderma Investigational Site
Salt Lake City, Utah, 84117
Galderma Investigational Site
San Diego, California, 92121
Galderma Investigational Site
San Diego, California, 92130
Galderma Investigational Site
Santa Monica, California, 94404
Galderma Investigational Site
Springville, Utah, 84663
Galderma Investigational Site
St Louis, Missouri, 63110
Galderma Investigational Site
Tampa, Florida, 33607
Galderma Investigational Site
Topeka, Kansas, 66614
Germany23 sites
Galderma Investigational Site
Aachen, 52074
Galderma Investigational Site
Augsburg, 86179
Galderma Investigational Site
Bad Bentheim, 48455
Galderma Investigational Site
Berlin, 10117
Galderma Investigational Site
Bonn, 53105
Galderma Investigational Site
Darmstadt, 64283
Galderma Investigational Site
Dresden, 01307
Galderma Investigational Site
Düsseldorf, 40225
Galderma Investigational Site
Eppendorf, 20246
Galderma Investigational Site
Erlangen, 91054
Galderma Investigational Site
Göttingen, 37075
Galderma Investigational Site
Halle, 06120
Galderma Investigational Site
Hamburg, 20537
Galderma Investigational Site
Heidelberg, 69115
Galderma Investigational Site
Kiel, 24105
Galderma Investigational Site
Lübeck, 23538
Galderma Investigational Site
Mainz, 55131
Galderma Investigational Site
Münich, 80337
Galderma Investigational Site
Münich, 80802
Galderma Investigational Site
Münster, 48149
Galderma Investigational Site
Oldenburg, 26133
Galderma Investigational Site
Tübingen, 72076
Galderma Investigational Site
Würzburg, 97080
Italy11 sites
Galderma Investigational Site
Catania, 95123
Galderma Investigational Site
Chieti, 66100
Galderma Investigational Site
Genova, 16132
Galderma Investigational Site
L’Aquila, 67100
Galderma Investigational Site
Modena, 41124
Galderma Investigational Site
Naples, 80131
Galderma Investigational Site
Parma, 43126
Galderma Investigational Site
Perugia, 06129
Galderma Investigational Site
Roma, 00144
Galderma Investigational Site
Roma, 00168
Galderma Investigational Site
Vicenza, 24128
Poland9 sites
Galderma Investigational Site
Częstochowa, 42-202
Galderma Investigational Site
Gdansk, 80-382
Galderma Investigational Site
Gdynia, 81-537
Galderma Investigational Site
Katowice, 40-040
Galderma Investigational Site
Lodz, 90-127
Galderma Investigational Site
Poznan, 60-702
Galderma Investigational Site
Rzeszów, 30-055
Galderma Investigational Site
Warsaw, 01-192
Galderma Investigational Site
Wroclaw, 50-381
Hungary6 sites
Galderma Investigational Site
Budapest, 1036
Galderma Investigational Site
Gyula, 5700
Galderma Investigational Site
Kecskemét, 6000
Galderma Investigational Site
Szeged, 6720
Galderma Investigational Site
Szolnok, 5000
Galderma Investigational Site
Zalaegerszeg, 8900
United Kingdom4 sites
Galderma Investigational Site
Dudley, DY1 2HQ
Galderma Investigational Site
Glasgow, G3 8SJ
Galderma Investigational Site
London, SE1 9RT
Galderma Investigational Site
Newcastle upon Tyne, NE1 4LP
Austria3 sites
Galderma Investigational Site
Graz, 8036
Galderma Investigational Site
Linz, 4020
Galderma Investigational Site
Vienna, 1220
Canada3 sites
Galderma Investigational Site
Calgary, AL, T3E OB2
Galderma Investigational Site
London, Ontario, N6A 3H7
Galderma Investigational Site
Saskatoon, Saskatchewan, S7K OH6
Denmark2 sites
Galderma Investigational Site
Aarhus, 8200
Galderma Investigational Site
Hellerup, 2900
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.
- Conditions
- Prurigo Nodularis
- Being tested
- Nemolizumab 30 mg, Placebo
- Keywords
- Prurigo, Neurodermatitis, Pruritus, Skin diseases
- Medical subject headings
- Prurigo, Neurodermatitis, Pruritus, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemolizumab 30 mgDrug
Also called CD14152
Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
PlaceboDrug
Participants received matching placebo as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab | Experimental | Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Receives: Drug: Nemolizumab 30 mg |
| Placebo | Placebo comparator | Participants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
The Peak 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. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Baseline, Week 16
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Baseline, Week 16
Secondary outcomes (6)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs occurring after the first administration of the study drug until the last study visit. SAE was any untoward medical occurrence, in the view of either the Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. AESI was a noteworthy TEAE for the study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.
Measured: From Baseline up to end of treatment period (24 weeks)
Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4
The Peak 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. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Baseline, Week 4
Number of Participants With PP NRS < 2 at Week 16
The Peak 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. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Week 16
Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16
The SD NRS is a scale to report the degree of participant sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Baseline, Week 16
Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4
SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responde
Measured: Baseline, Week 4
Number of Participants With PP NRS < 2 at Week 4
The Peak 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. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start11 Sep 2020
- Primary completion11 Nov 2022
- Study completion21 Feb 2023
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 Prurigo NodularisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 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
- NCT04501666
- Sponsor's protocol ID
- RD.06.SPR.202685
- Other IDs
- 2019-004293-25, 2019
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2020
- Last updated
- 10 Jul 2024
- 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 anonymized data sets from which results presented are derived.
Publications
Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333.
PubMed 37888917Stander S, Rodriguez DN, Dias-Barbosa C, Filipenko D, Puelles J, Jabbar-Lopez ZK, Piketty C, Wiegmann H, Kwatra SG. Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis. Dermatol Ther (Heidelb). 2025 Jun;15(6):1405-1426. doi: 10.1007/s13555-025-01406-1. Epub 2025 Apr 23.
PubMed 40266487Stander S, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Metz M, Tsianakas A, Pink A, Fage S, Micali G, Weisshaar E, Sundaram H, Metelitsa A, Augustin M, Wollenberg A, Homey B, Fargnoli MC, Sofen H, Korman NJ, Skov L, Chen X, Jabbar-Lopez ZK, Piketty C, Kwatra SG; OLYMPIA 1 Investigators. Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial. JAMA Dermatol. 2025 Feb 1;161(2):147-156. doi: 10.1001/jamadermatol.2024.4796.
PubMed 39602139
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT04501666
- Acronym / sponsor ID
- RD.06.SPR.202685
- Conditions
- Prurigo Nodularis
- Keywords
- Prurigo, Neurodermatitis, Pruritus, Skin diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab | Experimental | Drug: Nemolizumab 30 mgParticipants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits.
- Severe pruritus was defined as follows on the PP NRS:
- Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.
Key exclusion criteria (8 listed)
- Body weight less than < 30 kg.
- Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [e.g.] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
- Unilateral lesions of prurigo (e.g., only one arm affected).
- History of or current confounding skin condition (e.g., Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis).
- Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
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 |
|---|---|---|
| Nemolizumab 30 mgAlso: CD14152Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. | Drug | Nemolizumab |
| PlaceboParticipants received matching placebo as SC injection. | Drug | Placebo |
Primary outcome
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
Time frame: Baseline, Week 16
The Peak 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. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
Time frame: Baseline, Week 16
IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
6 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Time frame: From Baseline up to end of treatment period (24 weeks)
Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4
Time frame: Baseline, Week 4
Number of Participants With PP NRS < 2 at Week 16
Time frame: Week 16
Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16
Time frame: Baseline, Week 16
Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4
Time frame: Baseline, Week 4
Number of Participants With PP NRS < 2 at Week 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37888917Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333.
- Derived from this study: PubMed 40266487Stander S, Rodriguez DN, Dias-Barbosa C, Filipenko D, Puelles J, Jabbar-Lopez ZK, Piketty C, Wiegmann H, Kwatra SG. Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis. Dermatol Ther (Heidelb). 2025 Jun;15(6):1405-1426. doi: 10.1007/s13555-025-01406-1. Epub 2025 Apr 23.
- Derived from this study: PubMed 39602139Stander S, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Metz M, Tsianakas A, Pink A, Fage S, Micali G, Weisshaar E, Sundaram H, Metelitsa A, Augustin M, Wollenberg A, Homey B, Fargnoli MC, Sofen H, Korman NJ, Skov L, Chen X, Jabbar-Lopez ZK, Piketty C, Kwatra SG; OLYMPIA 1 Investigators. Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial. JAMA Dermatol. 2025 Feb 1;161(2):147-156. doi: 10.1001/jamadermatol.2024.4796.
- Description Phase 3 Trial of Nemolizumab in Patients with Prurigo NodularisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized data sets from which results presented are derived.
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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.
100 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nemolizumab 30 mg in people with Prurigo Nodularis, run by Galderma R&D at 100 sites in 10 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 6 inclusion and 8 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Germany, Italy, Poland, Hungary and 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Jul 2024). 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?
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 (time frame: Baseline, Week 16). The study lists 2 primary outcomes in all. 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 NCT04501666, 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 10 Jul 2024.