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

NCT04501666 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: RD.06.SPR.2026852019-004293-25
• Study Type: interventional
• Target: 286
• Locations: 10 countries
• Sites: 100

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 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.

  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.

  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)

  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

  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

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 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 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.

Drug: Placebo

Interventions

Nemolizumab 30 mg 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.
• 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.

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 \[e.g.\] 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (100)

Galderma Investigational Site

Birmingham, Alabama, 35233, United States

Location

Galderma Investigational Site

Birmingham, Alabama, 35244, United States

Location

Galderma Investigational Site

Los Angeles, California, 90045, United States

Location

Galderma Investigational Site

Sacramento, California, 95815, United States

Location

Galderma Investigational Site

San Diego, California, 92121, United States

Location

Galderma Investigational Site

San Diego, California, 92130, United States

Location

Galderma Investigational Site

Santa Monica, California, 94404, United States

Location

Galderma Investigational Site

Delray Beach, Florida, 33484, United States

Location

Galderma Investigational Site

Hollywood, Florida, 33021, United States

Location

Galderma Investigational Site

Largo, Florida, 33770, United States

Location

Galderma Investigational Site

Miami, Florida, 33125, United States

Location

Galderma Investigational Site

Pembroke Pines, Florida, 33028, United States

Location

Galderma Investigational Site

Tampa, Florida, 33607, United States

Location

Galderma Investigational Site

Columbus, Georgia, 31904, United States

Location

Galderma Investigational Site

Macon, Georgia, 31217, United States

Location

Galderma Investigational Site

Chicago, Illinois, 60613, United States

Location

Galderma Investigational Site

Lake Bluff, Illinois, 60044, United States

Location

Galderma Investigational Site

Topeka, Kansas, 66614, United States

Location

Galderma Investigational Site

Baltimore, Maryland, 21231, United States

Location

Galderma Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Galderma Investigational Site

Saint Joseph, Missouri, 64506, United States

Location

Galderma Investigational Site

St Louis, Missouri, 63110, United States

Location

Galderma Investigational Site

New York, New York, 10065, United States

Location

Galderma Investigational Site

High Point, North Carolina, 27262, United States

Location

Galderma Investigational Site

Raleigh, North Carolina, 27617, United States

Location

Galderma Investigational Site

Cleveland, Ohio, 44106, United States

Location

Galderma Investigational Site

Norman, Oklahoma, 73071, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Galderma Investigational Site

Johnston, Rhode Island, 02919, United States

Location

Galderma Investigational Site

Providence, Rhode Island, 02903, United States

Location

Galderma Investigational Site

Knoxville, Tennessee, 37909, United States

Location

Galderma Investigational Site

Austin, Texas, 78738, United States

Location

Galderma Investigational Site

Bellaire, Texas, 77401, United States

Location

Galderma Investigational Site

Laredo, Texas, 78401, United States

Location

Galderma Investigational Site

Salt Lake City, Utah, 84117, United States

Location

Galderma Investigational Site

Springville, Utah, 84663, United States

Location

Galderma Investigational Site

Fairfax, Virginia, 22031, United States

Location

Galderma Investigational Site

Graz, 8036, Austria

Location

Galderma Investigational Site

Linz, 4020, Austria

Location

Galderma Investigational Site

Vienna, 1220, Austria

Location

Galderma Investigational Site

Calgary, AL, T3E OB2, Canada

Location

Galderma Investigational Site

London, Ontario, N6A 3H7, Canada

Location

Galderma Investigational Site

Saskatoon, Saskatchewan, S7K OH6, Canada

Location

Galderma Investigational Site

Aarhus, 8200, Denmark

Location

Galderma Investigational Site

Hellerup, 2900, Denmark

Location

Galderma Investigational Site

Aachen, 52074, Germany

Location

Galderma Investigational Site

Augsburg, 86179, Germany

Location

Galderma Investigational Site

Bad Bentheim, 48455, Germany

Location

Galderma Investigational Site

Berlin, 10117, Germany

Location

Galderma Investigational Site

Bonn, 53105, Germany

Location

Galderma Investigational Site

Darmstadt, 64283, Germany

Location

Galderma Investigational Site

Dresden, 01307, Germany

Location

Galderma Investigational Site

Düsseldorf, 40225, Germany

Location

Galderma Investigational Site

Eppendorf, 20246, Germany

Location

Galderma Investigational Site

Erlangen, 91054, Germany

Location

Galderma Investigational Site

Göttingen, 37075, Germany

Location

Galderma Investigational Site

Halle, 06120, Germany

Location

Galderma Investigational Site

Hamburg, 20537, Germany

Location

Galderma Investigational Site

Heidelberg, 69115, Germany

Location

Galderma Investigational Site

Kiel, 24105, Germany

Location

Galderma Investigational Site

Lübeck, 23538, Germany

Location

Galderma Investigational Site

Mainz, 55131, Germany

Location

Galderma Investigational Site

Münich, 80337, Germany

Location

Galderma Investigational Site

Münich, 80802, Germany

Location

Galderma Investigational Site

Münster, 48149, Germany

Location

Galderma Investigational Site

Oldenburg, 26133, Germany

Location

Galderma Investigational Site

Tübingen, 72076, Germany

Location

Galderma Investigational Site

Würzburg, 97080, Germany

Location

Galderma Investigational Site

Budapest, 1036, Hungary

Location

Galderma Investigational Site

Gyula, 5700, Hungary

Location

Galderma Investigational Site

Kecskemét, 6000, Hungary

Location

Galderma Investigational Site

Szeged, 6720, Hungary

Location

Galderma Investigational Site

Szolnok, 5000, Hungary

Location

Galderma Investigational Site

Zalaegerszeg, 8900, Hungary

Location

Galderma Investigational Site

Catania, 95123, Italy

Location

Galderma Investigational Site

Chieti, 66100, Italy

Location

Galderma Investigational Site

Genova, 16132, Italy

Location

Galderma Investigational Site

L’Aquila, 67100, Italy

Location

Galderma Investigational Site

Modena, 41124, Italy

Location

Galderma Investigational Site

Napoli, 80131, Italy

Location

Galderma Investigational Site

Parma, 43126, Italy

Location

Galderma Investigational Site

Perugia, 06129, Italy

Location

Galderma Investigational Site

Roma, 00144, Italy

Location

Galderma Investigational Site

Roma, 00168, Italy

Location

Galderma Investigational Site

Vicenza, 24128, Italy

Location

Galderma Investigational Site

Częstochowa, 42-202, Poland

Location

Galderma Investigational Site

Gdansk, 80-382, Poland

Location

Galderma Investigational Site

Gdynia, 81-537, Poland

Location

Galderma Investigational Site

Katowice, 40-040, Poland

Location

Galderma Investigational Site

Lodz, 90-127, Poland

Location

Galderma Investigational Site

Poznan, 60-702, Poland

Location

Galderma Investigational Site

Rzeszów, 30-055, Poland

Location

Galderma Investigational Site

Warsaw, 01-192, Poland

Location

Galderma Investigational Site

Wroclaw, 50-381, Poland

Location

Galderma Investigational Site

Solna, 17176, Sweden

Location

Galderma Investigational Site

Dudley, DY1 2HQ, United Kingdom

Location

Galderma Investigational Site

Glasgow, G3 8SJ, United Kingdom

Location

Galderma Investigational Site

London, SE1 9RT, United Kingdom

Location

Galderma Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (3)

• 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

• 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.

  PMID: 39602139 DERIVED

Related Links

• Description Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis

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
• 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: September 11, 2020
• Primary Completion: November 11, 2022
• Study Completion: February 21, 2023
• 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

AU (3); US (38); CA (3); SE (1); DE (23); HU (6); GB (4); DK (2); IT (11); PL (9)