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New drug shows promise for chronic itch in Long-Term trial

NCT ID NCT04204616

Symptom relief Sponsor: Galderma R&D Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of nemolizumab in 500 adults with prurigo nodularis, a condition causing severe itching and skin bumps. Participants must have taken nemolizumab in a previous study. The main goal is to track side effects over time, while also checking if the drug helps clear the skin.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

prurigo nodularis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prurigo nodularis

Contacts and locations

Locations

  • Galderma I Galderma Investigational Site

    Lake Bluff, Illinois, 60044, United States

  • Galderma Investigational Galderma Investigational Site

    Columbus, Georgia, 31904, United States

  • Galderma Investigational Galderma Investigational Site

    Chicago, Illinois, 60613, United States

  • Galderma Investigational Galderma Investigational Site

    New York, New York, 10065, United States

  • Galderma Investigational Galderma Investigational Site

    Austin, Texas, 78738, United States

  • Galderma Investigational Galderma Investigational Site

    Springville, Utah, 84663, United States

  • Galderma Investigational Site

    Birmingham, Alabama, 35233, United States

  • Galderma Investigational Site

    Birmingham, Alabama, 35244, United States

  • Galderma Investigational Site

    Fountain Valley, California, 92708, United States

  • Galderma Investigational Site

    Los Angeles, California, 90045, United States

  • Galderma Investigational Site

    San Diego, California, 92123, United States

  • Galderma Investigational Site

    San Diego, California, 92130, United States

  • Galderma Investigational Site

    Santa Monica, California, 94404, United States

  • Galderma Investigational Site

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

  • Galderma Investigational Site

    Aventura, Florida, 33180, United States

  • Galderma Investigational Site

    Delray Beach, Florida, 33484, United States

  • Galderma Investigational Site

    Hollywood, Florida, 33021, United States

  • Galderma Investigational Site

    Largo, Florida, 33770, United States

  • Galderma Investigational Site

    Miami, Florida, 33125, United States

  • Galderma Investigational Site

    Miami, Florida, 33136, United States

  • Galderma Investigational Site

    North Miami Beach, Florida, 33162, United States

  • Galderma Investigational Site

    Ormond Beach, Florida, 32174, United States

  • Galderma Investigational Site

    Pembroke Pines, Florida, 33028, United States

  • Galderma Investigational Site

    Tampa, Florida, 33607, United States

  • Galderma Investigational Site

    Macon, Georgia, 31217, United States

  • Galderma Investigational Site

    Newnan, Georgia, 30263, United States

  • Galderma Investigational Site

    Chicago, Illinois, 60602, United States

  • Galderma Investigational Site

    Indianapolis, Indiana, 46250, United States

  • Galderma Investigational Site

    Topeka, Kansas, 66614, United States

  • Galderma Investigational Site

    Louisville, Kentucky, 40241, United States

  • Galderma Investigational Site

    Baltimore, Maryland, 21231, United States

  • Galderma Investigational Site

    Boston, Massachusetts, 02111, United States

  • Galderma Investigational Site

    Ann Arbor, Michigan, 48109, United States

  • Galderma Investigational Site

    Saint Joseph, Michigan, 49085, United States

  • Galderma Investigational Site

    Saint Joseph, Missouri, 64506, United States

  • Galderma Investigational Site

    St Louis, Missouri, 63110, United States

  • Galderma Investigational Site

    Henderson, Nevada, 89052, United States

  • Galderma Investigational Site

    New York, New York, 10021, United States

  • Galderma Investigational Site

    High Point, North Carolina, 27262, United States

  • Galderma Investigational Site

    Raleigh, North Carolina, 27617, United States

  • Galderma Investigational Site

    Winston-Salem, North Carolina, 27104, United States

  • Galderma Investigational Site

    Cincinnati, Ohio, 45627, United States

  • Galderma Investigational Site

    Cleveland, Ohio, 44106, United States

  • Galderma Investigational Site

    Dublin, Ohio, 43016, United States

  • Galderma Investigational Site

    Philadelphia, Pennsylvania, 19103, United States

  • Galderma Investigational Site

    Anderson, South Carolina, 29621, United States

  • Galderma Investigational Site

    Knoxville, Tennessee, 37909, United States

  • Galderma Investigational Site

    Murfreesboro, Tennessee, 37130, United States

  • Galderma Investigational Site

    Dallas, Texas, 75230, United States

  • Galderma Investigational Site

    Dripping Springs, Texas, 78620, United States

  • Galderma Investigational Site

    Houston, Texas, 77401, United States

  • Galderma Investigational Site

    Pflugerville, Texas, 78660, United States

  • Galderma Investigational Site

    Webster, Texas, 77004, United States

  • Galderma Investigational Site

    Salt Lake City, Utah, 84117, United States

  • Galderma Investigational Site

    Fairfax, Virginia, 22031, United States

  • Galderma Investigational Site

    Lynchburg, Virginia, 24501, United States

  • Galderma Investigational Site

    Morgantown, West Virginia, 26505, United States

  • Galderma Investigational Site

    Graz, 8036, Austria

  • Galderma Investigational Site

    Linz, 4020, Austria

  • Galderma Investigational Site

    Vienna, 1220, Austria

  • Galderma Investigational Site

    Brussels, 1200, Belgium

  • Galderma Investigational Site

    Ghent, 9000, Belgium

  • Galderma Investigational Site

    Jette, 1090, Belgium

  • Galderma Investigational Site

    Leuven, 3000, Belgium

  • Galderma Investigational Site

    Liège, 4000, Belgium

  • Galderma Investigational Site

    Calgary, AL, T3E OB2, Canada

  • Galderma Investigational Site

    London, Ontario, N6A 3H7, Canada

  • Galderma Investigational Site

    North York, Ontario, M2M 4J5, Canada

  • Galderma Investigational Site

    Saskatoon, Saskatchewan, S7K OH6, Canada

  • Galderma Investigational Site

    Calgary, T2G 1B1, Canada

  • Galderma Investigational Site

    London, N6H 5L5, Canada

  • Galderma Investigational Site

    Markham, L3P 1X2, Canada

  • Galderma Investigational Site

    Toronto, M3H 5Y8, Canada

  • Galderma Investigational Site

    Aarhus, 8200, Denmark

  • Galderma Investigational Site

    Hellerup, 2900, Denmark

  • Galderma Investigational Site

    Bordeaux, 33000, France

  • Galderma Investigational Site

    Brest, 29200, France

  • Galderma Investigational Site

    Nantes, 44093, France

  • Galderma Investigational Site

    Nice, 06202, France

  • Galderma Investigational Site

    Paris, 75020, France

  • Galderma Investigational Site

    Paris, 75475, France

  • Galderma Investigational Site

    Pierre-Bénite, 69495, France

  • Galderma Investigational Site

    Rouen, 76000, France

  • Galderma Investigational Site

    Saint-Etienne, 42055, France

  • Galderma Investigational Site

    Toulouse, 31000, France

  • Galderma Investigational Site

    Valence, 26953, France

  • Galderma Investigational Site

    Aachen, 52074, Germany

  • Galderma Investigational Site

    Augsburg, 86179, Germany

  • Galderma Investigational Site

    Bad Bentheim, 48455, Germany

  • Galderma Investigational Site

    Bonn, 53105, Germany

  • Galderma Investigational Site

    Darmstadt, 64297, Germany

  • Galderma Investigational Site

    Dresden, 01307, Germany

  • Galderma Investigational Site

    Düsseldorf, 40225, Germany

  • Galderma Investigational Site

    Eppendorf, 20246, Germany

  • Galderma Investigational Site

    Göttingen, 37075, Germany

  • Galderma Investigational Site

    Halle, 06120, Germany

  • Galderma Investigational Site

    Hamburg, 20251, Germany

  • Galderma Investigational Site

    Heidelberg, 69115, Germany

  • Galderma Investigational Site

    Kiel, 24105, Germany

  • Galderma Investigational Site

    Lübeck, 23538, Germany

  • Galderma Investigational Site

    Mainz, 55131, Germany

  • Galderma Investigational Site

    Münich, 80337, Germany

  • Galderma Investigational Site

    Münich, 80802, Germany

  • Galderma Investigational Site

    Münster, 48149, Germany

  • Galderma Investigational Site

    Tübingen, 72076, Germany

  • Galderma Investigational Site

    Kecskemét, 6000, Hungary

  • Galderma Investigational Site

    Szeged, 6720, Hungary

  • Galderma Investigational Site

    Szolnok, 5000, Hungary

  • Galderma Investigational Site

    Catania, 95123, Italy

  • Galderma Investigational Site

    Chieti, 66100, Italy

  • Galderma Investigational Site

    Genova, 16132, Italy

  • Galderma Investigational Site

    L’Aquila, 67100, Italy

  • Galderma Investigational Site

    Modena, 41124, Italy

  • Galderma Investigational Site

    Naples, 80131, Italy

  • Galderma Investigational Site

    Parma, 43126, Italy

  • Galderma Investigational Site

    Perugia, 06129, Italy

  • Galderma Investigational Site

    Roma, 00144, Italy

  • Galderma Investigational Site

    Roma, 00168, Italy

  • Galderma Investigational Site

    Vicenza, 36100, Italy

  • Galderma Investigational Site

    Groningen, 9700, Netherlands

  • Galderma Investigational Site

    Utrecht, 3508, Netherlands

  • Galderma Investigational Site

    Bydgoszcz, 85-065, Poland

  • Galderma Investigational Site

    Chorzów, 41-500, Poland

  • Galderma Investigational Site

    Częstochowa, 42-202, Poland

  • Galderma Investigational Site

    Gdansk, 80-382, Poland

  • Galderma Investigational Site

    Gdynia, 81-537, Poland

  • Galderma Investigational Site

    Katowice, 40-040, Poland

  • Galderma Investigational Site

    Krakow, 31-559, Poland

  • Galderma Investigational Site

    Lodz, 90-127, Poland

  • Galderma Investigational Site

    Lodz, 90-265, Poland

  • Galderma Investigational Site

    Lodz, 90-436, Poland

  • Galderma Investigational Site

    Lublin, 20-081, Poland

  • Galderma Investigational Site

    Olsztyn, 10-900, Poland

  • Galderma Investigational Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Galderma Investigational Site

    Poznan, 60-702, Poland

  • Galderma Investigational Site

    Rzeszów, 35-055, Poland

  • Galderma Investigational Site

    Szczecin, 71-434, Poland

  • Galderma Investigational Site

    Warsaw, 01-192, Poland

  • Galderma Investigational Site

    Warsaw, 01-518, Poland

  • Galderma Investigational Site

    Warsaw, 01-817, Poland

  • Galderma Investigational Site

    Warsaw, 02-507, Poland

  • Galderma Investigational Site

    Warsaw, 02-758, Poland

  • Galderma Investigational Site

    Wroclaw, 50-381, Poland

  • Galderma Investigational Site

    Wroclaw, 50-566, Poland

  • Galderma Investigational Site

    Wroclaw, 51-318, Poland

  • Galderma Investigational Site

    Gyeonggi-do, 15355, South Korea

  • Galderma Investigational Site

    Seoul, 02841, South Korea

  • Galderma Investigational Site

    Seoul, 03722, South Korea

  • Galderma Investigational Site

    Seoul, 04763, South Korea

  • Galderma Investigational Site

    Seoul, 07441, South Korea

  • Galderma Investigational Site

    Barcelona, 08041, Spain

  • Galderma Investigational Site

    Las Palmas de Gran Canaria, 35019, Spain

  • Galderma Investigational Site

    Solna, 17176, Sweden

  • Galderma Investigational Site

    Bern, 3010, Switzerland

  • Galderma Investigational Site

    Buochs, 6374, Switzerland

  • Galderma Investigational Site

    Lausanne, 1011, Switzerland

  • Galderma Investigational Site

    Obbürgen, 6363, Switzerland

  • Galderma Investigational Site

    Sankt Gallen, 9007, Switzerland

  • Galderma Investigational Site

    Weinfelden, 8570, Switzerland

  • Galderma Investigational Site

    Dudley, DY1 2HQ, United Kingdom

  • Galderma Investigational Site

    Glasgow, G3 8SJ, United Kingdom

  • Galderma Investigational Site

    London, SE1 9RT, United Kingdom

  • Galderma Investigational Site

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Galderme Investigational Site

    Berlin, 10117, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.