A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: RD.06.SPR.2030652019-004789-17
• Study Type: interventional
• Target: 274
• Locations: 9 countries
• Sites: 74

Brief 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.

Conditions

Prurigo Nodularis

Keywords

Prurigo; Neurodermatitis; Pruritus; Skin diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 16

Secondary Outcomes (6)

• Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4

  Baseline, Week 4

• Number of Participants With PP NRS < 2 at Week 16

  Week 16

• Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16

  Baseline, Week 16

• Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4

  Baseline, Week 4

• Number of Participants With PP NRS < 2 at Week 4

  Week 4

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Nemolizumab DRUG

Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.

Also known as: CD14152

Nemolizumab

Placebo DRUG

Participants received matching placebo as SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (74)

Galderma Investigational Site

Fountain Valley, California, 92708, United States

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Galderma Investigational Site

San Diego, California, 92123, United States

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Galderma Investigational Site

Washington D.C., District of Columbia, 20037, United States

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Galderma Investigational Site

Aventura, Florida, 33180, United States

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Galderma Investigational Site

Miami, Florida, 33136, United States

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Galderma Investigational Site

North Miami Beach, Florida, 33162-4708, United States

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Galderma Investigational Site

Ormond Beach, Florida, 32174, United States

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Galderma Investigational Site

Chicago, Illinois, 60602, United States

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Galderma Investigational Site

Indianapolis, Indiana, 46250, United States

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Galderma Investigational Site

Louisville, Kentucky, 40241, United States

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Galderma Investigational Site

Boston, Massachusetts, 02111, United States

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Galderma Investigational Site

Saint Joseph, Michigan, 49085, United States

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Galderma Investigational Site

New York, New York, 10021, United States

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Galderma Investigational Site

Cincinnati, Ohio, 45627, United States

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Galderma Investigational Site

Dublin, Ohio, 43016, United States

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Galderma Investigational Site

Anderson, South Carolina, 29621, United States

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Galderma Investigational Site

Murfreesboro, Tennessee, 37130, United States

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Galderma Investigational Site

Dallas, Texas, 75230, United States

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Galderma Investigational Site

Dripping Springs, Texas, 78620, United States

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Galderma Investigational Site

Pflugerville, Texas, 78660, United States

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Galderma Investigational Site

Webster, Texas, 77004, United States

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Galderma Investigational Site

Morgantown, West Virginia, 26505, United States

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Galderma Investigational Site

Brussels, 1200, Belgium

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Galderma Investigational Site

Ghent, 9000, Belgium

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Galderma Investigational Site

Jette, 1090, Belgium

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Galderma Investigational Site

Leuven, 3000, Belgium

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Galderma Investigational Site

Liège, 4000, Belgium

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Galderma Investigational Site

North York, Ontario, M2M 4J5, Canada

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Galderma Investigational Site

Bathurst, M3H 5Y8, Canada

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Galderma Investigational Site

Calgary, T2G 1B1, Canada

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Galderma Investigational Site

London, N6H 5L5, Canada

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Galderma Investigational Site

Markham, L3P 1X2, Canada

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Galderma Investigational Site

Bordeaux, 33000, France

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Galderma Investigational Site

Brest, 29200, France

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Galderma Investigational Site

Lille, 59037, France

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Galderma Investigational Site

Nantes, 44093, France

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Galderma Investigational Site

Nice, 06202, France

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Galderma Investigational Site

Paris, 75020, France

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Galderma Investigational Site

Paris, 75475, France

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Galderma Investigational Site

Pierre-Bénite, 69495, France

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Galderma Investigational Site

Rouen, 76000, France

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Galderma Investigational Site

Saint-Etienne, 42055, France

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Galderma Investigational Site

Toulouse, 31000, France

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Galderma Investigational Site

Valence, 26953, France

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Galderma Investigational Site

Groningen, 9713, Netherlands

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Galderma Investigational Site

Utrecht, 3508, Netherlands

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Galderma Investigational Site

Bydgoszcz, 85-065, Poland

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Galderma Investigational Site

Chorzów, 41-500, Poland

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Galderma Investigational Site

Krakow, 31-559, Poland

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Galderma Investigational Site

Lodz, 90-265, Poland

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Galderma Investigational Site

Lodz, 90-436, Poland

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Galderma Investigational Site

Lublin, 20-081, Poland

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Galderma Investigational Site

Olsztyn, 10-229, Poland

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Galderma Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

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Galderma Investigational Site

Rzeszów, 35-055, Poland

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Galderma Investigational Site

Szczecin, 71-434, Poland

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Galderma Investigational Site

Warsaw, 01-518, Poland

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Galderma Investigational Site

Warsaw, 01-817, Poland

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Galderma Investigational Site

Warsaw, 02-507, Poland

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Galderma Investigational Site

Warsaw, 02-758, Poland

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Galderma Investigational Site

Wroclaw, 50-566, Poland

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Galderma Investigational Site

Wroclaw, 51-318, Poland

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Galderma Investigational Site

Gyeonggi-do, 15355, South Korea

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Galderma Investigational Site

Seoul, 02841, South Korea

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Galderma Investigational Site

Seoul, 03722, South Korea

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Galderma Investigational Site

Seoul, 04763, South Korea

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Galderma Investigational Site

Seoul, 07441, South Korea

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Galderma Investigational Site

Barcelona, 08041, Spain

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Galderma Investigational Site

Las Palmas de Gran Canaria, 35019, Spain

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Galderma Investigational Site

Bern, 3010, Switzerland

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Galderma Investigational Site

Buochs, 6374, Switzerland

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Galderma Investigational Site

Lausanne, 1011, Switzerland

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Galderma Investigational Site

Sankt Gallen, 9007, Switzerland

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Galderma Investigational Site

Weinfelden, 8570, Switzerland

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Related Publications (2)

• 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.

  PMID: 37888917 RESULT

• Stander 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.

  PMID: 40266487 DERIVED

MeSH Terms

Conditions

Prurigo; Neurodermatitis; Pruritus; Skin Diseases

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: August 11, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 31, 2022
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data availability will begin 6 months after approval of the indication by a regulatory body. Data availability will end 5 years from publication of the primary study results article.
• Access Criteria: Data will be made available to qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. Proposals should be directed to clinical.studies@galderma.com

Locations

ES (2); CH (5); PL (16); CA (5); FR (12); NL (2); KR (5); BE (5); US (22)