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

NCT ID: NCT04501679

Last Updated: 2024-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prurigo Nodularis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nemolizumab

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.

Group Type EXPERIMENTAL

Nemolizumab

Intervention Type DRUG

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants received matching placebo as SC injection.

Interventions

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Nemolizumab

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

Intervention Type DRUG

Placebo

Participants received matching placebo as SC injection.

Intervention Type DRUG

Other Intervention Names

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CD14152

Eligibility Criteria

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Inclusion Criteria

* 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:

1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit.
2. 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Investigational Site

Fountain Valley, California, United States

Site Status

Galderma Investigational Site

San Diego, California, United States

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Galderma Investigational Site

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

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Galderma Investigational Site

Aventura, Florida, United States

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Galderma Investigational Site

Miami, Florida, United States

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Galderma Investigational Site

North Miami Beach, Florida, United States

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Galderma Investigational Site

Ormond Beach, Florida, United States

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Galderma Investigational Site

Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Saint Joseph, Michigan, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Dublin, Ohio, United States

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Galderma Investigational Site

Anderson, South Carolina, United States

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Murfreesboro, Tennessee, United States

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Dallas, Texas, United States

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Dripping Springs, Texas, United States

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Pflugerville, Texas, United States

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Webster, Texas, United States

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Morgantown, West Virginia, United States

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Galderma Investigational Site

Brussels, , Belgium

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Galderma Investigational Site

Ghent, , Belgium

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Jette, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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North York, Ontario, Canada

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Bathurst, , Canada

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Calgary, , Canada

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London, , Canada

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Markham, , Canada

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Bordeaux, , France

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Brest, , France

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Lille, , France

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Nantes, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Rouen, , France

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Saint-Etienne, , France

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Toulouse, , France

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Valence, , France

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Groningen, , Netherlands

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Galderma Investigational Site

Utrecht, , Netherlands

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Galderma Investigational Site

Bydgoszcz, , Poland

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Chorzów, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Rzeszów, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Galderma Investigational Site

Wroclaw, , Poland

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Galderma Investigational Site

Wroclaw, , Poland

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Galderma Investigational Site

Gyeonggi-do, , South Korea

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Galderma Investigational Site

Seoul, , South Korea

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Galderma Investigational Site

Seoul, , South Korea

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Galderma Investigational Site

Seoul, , South Korea

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Galderma Investigational Site

Seoul, , South Korea

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Galderma Investigational Site

Barcelona, , Spain

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Galderma Investigational Site

Las Palmas de Gran Canaria, , Spain

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Galderma Investigational Site

Bern, , Switzerland

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Galderma Investigational Site

Buochs, , Switzerland

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Galderma Investigational Site

Lausanne, , Switzerland

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Galderma Investigational Site

Sankt Gallen, , Switzerland

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Galderma Investigational Site

Weinfelden, , Switzerland

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Countries

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United States Belgium Canada France Netherlands Poland South Korea Spain Switzerland

References

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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.

Reference Type RESULT
PMID: 37888917 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40266487 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-004789-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.06.SPR.203065

Identifier Type: -

Identifier Source: org_study_id

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