A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04204616 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: RD.06.SPR.2026992019-004294-13
• Study Type: interventional
• Target: 500
• Locations: 16 countries
• Sites: 164

Brief Summary

The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) by Severity

  Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.

  Up to 192 weeks

Secondary Outcomes (25)

• Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184

  Up to Week 184

• Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184

  Baseline up to Week 184

• Percentage of Participants with Low Disease Activity State up to Week 184

  Up to Week 184

• Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184

  Up to Week 184

• Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184

  Up to Week 184

Study Arms (1)

Nemolizumab

EXPERIMENTAL

Participants weighing less than (\<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (\>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.

Drug: Nemolizumab

Interventions

Nemolizumab DRUG

Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Also known as: CD14152

Nemolizumab

Eligibility Criteria

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

You may qualify if:

• Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
• Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
• Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
• Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

You may not qualify if:

• Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
• Body weight \< 30 kg
• Pregnant women (positive pregnancy test result at screening or baseline visit or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study
• Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
• Planning or expected to have a major surgical procedure during the clinical study
• Participants unwilling to refrain from using prohibited medications during the clinical study
• History of alcohol or substance abuse within 6 months prior to the screening visit or re-entry Week R0 visit

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (164)

Galderma Investigational Site

Birmingham, Alabama, 35233, United States

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Galderma Investigational Site

Birmingham, Alabama, 35244, United States

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Fountain Valley, California, 92708, United States

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Los Angeles, California, 90045, United States

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Galderma Investigational Site

San Diego, California, 92123, United States

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Galderma Investigational Site

San Diego, California, 92130, United States

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Santa Monica, California, 94404, United States

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

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Aventura, Florida, 33180, United States

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Delray Beach, Florida, 33484, United States

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Galderma Investigational Site

Hollywood, Florida, 33021, United States

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Galderma Investigational Site

Largo, Florida, 33770, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33136, United States

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North Miami Beach, Florida, 33162, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33028, United States

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Tampa, Florida, 33607, United States

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Galderma Investigational Galderma Investigational Site

Columbus, Georgia, 31904, United States

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Macon, Georgia, 31217, United States

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Newnan, Georgia, 30263, United States

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Chicago, Illinois, 60602, United States

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Galderma Investigational Galderma Investigational Site

Chicago, Illinois, 60613, United States

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Galderma I Galderma Investigational Site

Lake Bluff, Illinois, 60044, United States

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Indianapolis, Indiana, 46250, United States

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Topeka, Kansas, 66614, United States

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Louisville, Kentucky, 40241, United States

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Baltimore, Maryland, 21231, United States

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Boston, Massachusetts, 02111, United States

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Ann Arbor, Michigan, 48109, United States

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Saint Joseph, Michigan, 49085, United States

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Saint Joseph, Missouri, 64506, United States

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St Louis, Missouri, 63110, United States

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Henderson, Nevada, 89052, United States

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New York, New York, 10021, United States

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Galderma Investigational Galderma Investigational Site

New York, New York, 10065, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27617, United States

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Winston-Salem, North Carolina, 27104, United States

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Cincinnati, Ohio, 45627, United States

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Cleveland, Ohio, 44106, United States

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Dublin, Ohio, 43016, United States

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Philadelphia, Pennsylvania, 19103, United States

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Anderson, South Carolina, 29621, United States

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Knoxville, Tennessee, 37909, United States

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Murfreesboro, Tennessee, 37130, United States

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Galderma Investigational Galderma Investigational Site

Austin, Texas, 78738, United States

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Dallas, Texas, 75230, United States

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Dripping Springs, Texas, 78620, United States

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Houston, Texas, 77401, United States

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Pflugerville, Texas, 78660, United States

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Webster, Texas, 77004, United States

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Salt Lake City, Utah, 84117, United States

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Springville, Utah, 84663, United States

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Fairfax, Virginia, 22031, United States

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Lynchburg, Virginia, 24501, United States

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Morgantown, West Virginia, 26505, United States

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Graz, 8036, Austria

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Linz, 4020, Austria

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Vienna, 1220, Austria

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Jette, 1090, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Calgary, AL, T3E OB2, Canada

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London, Ontario, N6A 3H7, Canada

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North York, Ontario, M2M 4J5, Canada

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Saskatoon, Saskatchewan, S7K OH6, Canada

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Calgary, T2G 1B1, Canada

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London, N6H 5L5, Canada

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Markham, L3P 1X2, Canada

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Toronto, M3H 5Y8, Canada

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Aarhus, 8200, Denmark

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Hellerup, 2900, Denmark

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Bordeaux, 33000, France

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Brest, 29200, France

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Galderma Investigational Site

Nantes, 44093, France

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Nice, 06202, France

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Paris, 75020, France

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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

Aachen, 52074, Germany

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Galderma Investigational Site

Augsburg, 86179, Germany

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Galderma Investigational Site

Bad Bentheim, 48455, Germany

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Galderme Investigational Site

Berlin, 10117, Germany

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Bonn, 53105, Germany

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Darmstadt, 64297, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40225, Germany

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Eppendorf, 20246, Germany

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Göttingen, 37075, Germany

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Halle, 06120, Germany

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Hamburg, 20251, Germany

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Heidelberg, 69115, Germany

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Kiel, 24105, Germany

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Lübeck, 23538, Germany

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Mainz, 55131, Germany

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Münich, 80337, Germany

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Münich, 80802, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Kecskemét, 6000, Hungary

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Szeged, 6720, Hungary

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Szolnok, 5000, Hungary

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Catania, 95123, Italy

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Chieti, 66100, Italy

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Genova, 16132, Italy

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L’Aquila, 67100, Italy

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Modena, 41124, Italy

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Napoli, 80131, Italy

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Parma, 43126, Italy

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Perugia, 06129, Italy

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Roma, 00144, Italy

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Roma, 00168, Italy

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Vicenza, 36100, Italy

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Groningen, 9700, Netherlands

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Utrecht, 3508, Netherlands

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Bydgoszcz, 85-065, Poland

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Chorzów, 41-500, Poland

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Częstochowa, 42-202, Poland

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Gdansk, 80-382, Poland

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Gdynia, 81-537, Poland

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Katowice, 40-040, Poland

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Krakow, 31-559, Poland

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Lodz, 90-127, Poland

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Lodz, 90-265, Poland

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Lodz, 90-436, Poland

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Lublin, 20-081, Poland

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Olsztyn, 10-900, Poland

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Ostrowiec Świętokrzyski, 27-400, Poland

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Poznan, 60-702, Poland

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Rzeszów, 35-055, Poland

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Szczecin, 71-434, Poland

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Warsaw, 01-192, Poland

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Warsaw, 01-518, Poland

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Warsaw, 01-817, Poland

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Warsaw, 02-507, Poland

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Warsaw, 02-758, Poland

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Wroclaw, 50-381, Poland

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Wroclaw, 50-566, Poland

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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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Barcelona, 08041, Spain

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Galderma Investigational Site

Las Palmas de Gran Canaria, 35019, Spain

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Solna, 17176, Sweden

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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

Obbürgen, 6363, 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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Dudley, DY1 2HQ, United Kingdom

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Galderma Investigational Site

Glasgow, G3 8SJ, United Kingdom

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Galderma Investigational Site

London, SE1 9RT, United Kingdom

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Galderma Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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Related Publications (1)

• Legat FJ, Kwatra SG, Reich A, Boulinguez S, Tsianakas A, Sauder M, Barbarot S, Szepietowski JC, Conrad C, Pink AE, Weisshaar E, Misery L, Metz M, Laquer VT, Sivamani RK, Yosipovitch G, Thaci D, Skov L, Chen X, Noda A, Jabbar-Lopez ZK, Piketty C, Stander S. Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis. J Eur Acad Dermatol Venereol. 2025 Dec 17. doi: 10.1111/jdv.70266. Online ahead of print.

  PMID: 41405008 DERIVED

MeSH Terms

Interventions

nemolizumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: January 11, 2021
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

CH (6); AU (3); DE (20); BE (5); US (57); IT (11); HU (3); GB (4); DK (2); FR (11); SE (1); KR (5); CA (8); ES (2); NL (2); PL (24)