Prurigo NodularisPhase 3NCT04501679
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
A Phase 3 study testing Nemolizumab in people with Prurigo Nodularis, run by Galderma R&D at 74 sites in 9 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 11 Aug 2020to 31 Mar 2022
- 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
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 [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
- Unilateral lesions of prurigo (eg, only one arm affected)
- History of or current confounding skin condition (eg, 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 (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
United States22 sites
Galderma Investigational Site
Anderson, South Carolina, 29621
Galderma Investigational Site
Aventura, Florida, 33180
Galderma Investigational Site
Boston, Massachusetts, 02111
Galderma Investigational Site
Chicago, Illinois, 60602
Galderma Investigational Site
Cincinnati, Ohio, 45627
Galderma Investigational Site
Dallas, Texas, 75230
Galderma Investigational Site
Dripping Springs, Texas, 78620
Galderma Investigational Site
Dublin, Ohio, 43016
Galderma Investigational Site
Fountain Valley, California, 92708
Galderma Investigational Site
Indianapolis, Indiana, 46250
Galderma Investigational Site
Louisville, Kentucky, 40241
Galderma Investigational Site
Miami, Florida, 33136
Galderma Investigational Site
Morgantown, West Virginia, 26505
Galderma Investigational Site
Murfreesboro, Tennessee, 37130
Galderma Investigational Site
New York, New York, 10021
Galderma Investigational Site
North Miami Beach, Florida, 33162-4708
Galderma Investigational Site
Ormond Beach, Florida, 32174
Galderma Investigational Site
Pflugerville, Texas, 78660
Galderma Investigational Site
Saint Joseph, Michigan, 49085
Galderma Investigational Site
San Diego, California, 92123
Galderma Investigational Site
Washington D.C., District of Columbia, 20037
Galderma Investigational Site
Webster, Texas, 77004
Poland16 sites
Galderma Investigational Site
Bydgoszcz, 85-065
Galderma Investigational Site
Chorzów, 41-500
Galderma Investigational Site
Krakow, 31-559
Galderma Investigational Site
Lodz, 90-265
Galderma Investigational Site
Lodz, 90-436
Galderma Investigational Site
Lublin, 20-081
Galderma Investigational Site
Olsztyn, 10-229
Galderma Investigational Site
Ostrowiec Świętokrzyski, 27-400
Galderma Investigational Site
Rzeszów, 35-055
Galderma Investigational Site
Szczecin, 71-434
Galderma Investigational Site
Warsaw, 01-518
Galderma Investigational Site
Warsaw, 01-817
Galderma Investigational Site
Warsaw, 02-507
Galderma Investigational Site
Warsaw, 02-758
Galderma Investigational Site
Wroclaw, 50-566
Galderma Investigational Site
Wroclaw, 51-318
France12 sites
Galderma Investigational Site
Bordeaux, 33000
Galderma Investigational Site
Brest, 29200
Galderma Investigational Site
Lille, 59037
Galderma Investigational Site
Nantes, 44093
Galderma Investigational Site
Nice, 06202
Galderma Investigational Site
Paris, 75020
Galderma Investigational Site
Paris, 75475
Galderma Investigational Site
Pierre-Bénite, 69495
Galderma Investigational Site
Rouen, 76000
Galderma Investigational Site
Saint-Etienne, 42055
Galderma Investigational Site
Toulouse, 31000
Galderma Investigational Site
Valence, 26953
Belgium5 sites
Galderma Investigational Site
Brussels, 1200
Galderma Investigational Site
Ghent, 9000
Galderma Investigational Site
Jette, 1090
Galderma Investigational Site
Leuven, 3000
Galderma Investigational Site
Liège, 4000
Canada5 sites
Galderma Investigational Site
Bathurst, M3H 5Y8
Galderma Investigational Site
Calgary, T2G 1B1
Galderma Investigational Site
London, N6H 5L5
Galderma Investigational Site
Markham, L3P 1X2
Galderma Investigational Site
North York, Ontario, M2M 4J5
South Korea5 sites
Galderma Investigational Site
Gyeonggi-do, 15355
Galderma Investigational Site
Seoul, 02841
Galderma Investigational Site
Seoul, 03722
Galderma Investigational Site
Seoul, 04763
Galderma Investigational Site
Seoul, 07441
Switzerland5 sites
Galderma Investigational Site
Bern, 3010
Galderma Investigational Site
Buochs, 6374
Galderma Investigational Site
Lausanne, 1011
Galderma Investigational Site
Sankt Gallen, 9007
Galderma Investigational Site
Weinfelden, 8570
Netherlands2 sites
Galderma Investigational Site
Groningen, 9713
Galderma Investigational Site
Utrecht, 3508
Spain2 sites
Galderma Investigational Site
Barcelona, 08041
Galderma Investigational Site
Las Palmas de Gran Canaria, 35019
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, 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.
NemolizumabDrug
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 for 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 |
| 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 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 both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects 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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Measured: Baseline, Week 16
Secondary outcomes (6)
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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects 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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects 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 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 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). 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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects 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
The 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) (rounding to nearest whole number is not permitted). 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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
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. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Measured: Week 4
Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either 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 congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for 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 (16 Weeks)
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 Aug 2020
- Primary completion30 Mar 2022
- Study completion31 Mar 2022
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 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
- 274 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
- NCT04501679
- Sponsor's protocol ID
- RD.06.SPR.203065
- Other IDs
- 2019-004789-17, 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 40266487
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
- NCT04501679
- Acronym / sponsor ID
- RD.06.SPR.203065
- Conditions
- Prurigo Nodularis
- Keywords
- Prurigo, Neurodermatitis, Pruritus, Skin diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (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: NemolizumabParticipants 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 for 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 (5 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
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 [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
- Unilateral lesions of prurigo (eg, only one arm affected)
- History of or current confounding skin condition (eg, 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 |
|---|---|---|
| NemolizumabAlso: 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 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 both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects 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 subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
6 secondary outcomes
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
Number of Participants With Adverse Events, 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 (16 Weeks)
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.
- 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.
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nemolizumab in people with Prurigo Nodularis, run by Galderma R&D at 74 sites in 9 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 5 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 74 sites in United States, Poland, France, Belgium, Canada and 4 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 NCT04501679, 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 10 Jul 2024.