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

NCT ID: NCT04501666

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

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2023-02-21

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 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 30 mg

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 30 mg

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.
* 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.

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 \[e.g.\] 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.
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

Birmingham, Alabama, United States

Site Status

Galderma Investigational Site

Birmingham, Alabama, United States

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Galderma Investigational Site

Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Delray Beach, Florida, United States

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Hollywood, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Columbus, Georgia, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Lake Bluff, Illinois, United States

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Topeka, Kansas, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Saint Joseph, Missouri, United States

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St Louis, Missouri, United States

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New York, New York, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Norman, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Providence, Rhode Island, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Laredo, Texas, United States

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Salt Lake City, Utah, United States

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Springville, Utah, United States

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Fairfax, Virginia, United States

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Graz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Calgary, AL, Canada

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London, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Aarhus, , Denmark

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Hellerup, , Denmark

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Aachen, , Germany

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Augsburg, , Germany

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Bad Bentheim, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Darmstadt, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Eppendorf, , Germany

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Erlangen, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Münich, , Germany

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Münich, , Germany

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Münster, , Germany

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Oldenburg, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Gyula, , Hungary

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Kecskemét, , Hungary

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Szeged, , Hungary

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Szolnok, , Hungary

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Zalaegerszeg, , Hungary

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Catania, , Italy

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Chieti, , Italy

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Genova, , Italy

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L’Aquila, , Italy

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Modena, , Italy

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Napoli, , Italy

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Parma, , Italy

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Perugia, , Italy

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Roma, , Italy

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Roma, , Italy

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Vicenza, , Italy

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Częstochowa, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Rzeszów, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Galderma Investigational Site

Solna, , Sweden

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Dudley, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Galderma Investigational Site

Newcastle upon Tyne, , United Kingdom

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Countries

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United States Austria Canada Denmark Germany Hungary Italy Poland Sweden United Kingdom

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)

Stander 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.

Reference Type DERIVED
PMID: 39602139 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.nejm.org/doi/full/10.1056/NEJMoa2301333

Description Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis

Other Identifiers

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2019-004293-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.06.SPR.202685

Identifier Type: -

Identifier Source: org_study_id

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