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New drug KPL-716 aims to stop the itch of prurigo nodularis

NCT ID NCT03816891

Symptom relief Sponsor: Genentech, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested an investigational drug called KPL-716 (vixarelimab) in 240 adults with prurigo nodularis, a skin condition causing intense itching and hard nodules. The study compared the drug to a placebo to see if it could reduce itch severity over several weeks. The goal is to find a new option for people who suffer from this chronic, hard-to-treat itch.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vixarelimab (KPL-716)
What this could lead to
If successful, this could lead to a new treatment that significantly reduces severe itching in people with prurigo nodularis.
What could go wrong
This is a mid-stage trial with 240 participants, so results may not confirm effectiveness or safety. The drug may not work better than placebo, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

240 people

The number who actually took part.

Started

Mar 2019

Finished

Aug 2023

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 to 80 years

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 (apply to both Phase 2a and Phase 2b unless otherwise specified): 1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b) 2. Have clinical diagnosis of prurigo nodularis for at least 6 months 3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1 4. Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b) 5. Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration 6. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study Exclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified): 1. Use of prohibited medications within the indicated timeframe from Day 1 2. Is currently using medication known to cause pruritus 3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor 4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit 5. Has an active infection, including skin infection 6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the subject at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results

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Conditions

The condition(s) this trial relates to.

prurigo nodularis Pruritus

As listed by the trial registrant

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

Prurigo nodularis Pruritis

Contacts and locations

Locations

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, Sicily, 95123, Italy

  • ALLCUTIS Research, LLC

    Beverly, Massachusetts, 01915, United States

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts, 01844, United States

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607, United States

  • Advanced Medical Research PC

    Sandy Springs, Georgia, 30328, United States

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3, Canada

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615, United States

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas, 78660, United States

  • Barts Health NHS Trust, Whipps Cross Hospital

    Leytonstone, E11 1NR, United Kingdom

  • Bobby Buka MD, PC

    New York, New York, 10012, United States

  • Broadgreen Hospital

    Liverpool, L14 3AB, United Kingdom

  • Brunswick Dermatology Center

    Fredericton, New Brunswick, E3B 1G9, Canada

  • CCR Czech a.s.

    Pardubice, 53 002, Czechia

  • CHU Nantes - Service de Dermatologie

    Nantes, 44093, France

  • CHU de Liège

    Liège, 4000, Belgium

  • CLINTRIAL s.r.o.

    Prague, 10000, Czechia

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538, United States

  • Central Alberta Research Clinic (CARe Clinic)

    Red Deer, Alberta, T4N6V7, Canada

  • Chang Gung Memorial Hospital

    Taoyuan City, 333, Taiwan

  • Cliniques Universitaires Saint-Luc (UCL St-Luc)

    Brussels, 1200, Belgium

  • Colorado Center for Dermatology, PLLC

    Centennial, Colorado, 80111, United States

  • DS Research

    New Albany, Indiana, 47150, United States

  • DS Research

    Louisville, Kentucky, 40241, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • DermEffects

    London, Ontario, N6H 5L5, Canada

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202, United States

  • Drc Angélique Gagné-Henley MD Inc.

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • Eberhard-Karls-University

    Tübingen, 72076, Germany

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455, Germany

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • George Washington University Medical Faculty Associates

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

  • George-August-Universität Göttingen

    Göttingen, 37075, Germany

  • Grażyna Pulka Centrum Medyczne All-Med

    Krakow, 30-033, Poland

  • Grekin Skin Institute

    Warren, Michigan, 08088, United States

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059, United States

  • Hautarztpraxis Dr. Hoffmann

    Witten, 58453, Germany

  • Hôpital Morvan - CHU Brest

    Brest, 29609, France

  • Hôpital Saint André - CHU de Bordeaux

    Bordeaux, 33075, France

  • Integrated Clinical Research

    West Palm Beach, Florida, 33406, United States

  • Investigate MD, LLC

    Scottsdale, Arizona, 85255, United States

  • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii

    Rzeszów, 35-055, Poland

  • Klinikum Bielefeld Rosenhöhe

    Bielefeld, North Rhine-Westphalia, 33647, Germany

  • Kyclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-367, Poland

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X2, Canada

  • Medical University of Graz

    Graz, 8036, Austria

  • Medical University of South Carolina, Department of Dermatology and Dermatological Surgery

    Charleston, South Carolina, 29425, United States

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Michigan Center for Skin Care Research

    Clinton Township, Michigan, 48038, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Olympian Clinical Research

    Largo, Florida, 33770, United States

  • Olympian Clinical Research

    St. Petersburg, Florida, 33709, United States

  • Olympian Clinical Research

    Tampa, Florida, 33614, United States

  • Paddington Testing Co., Inc.

    Philadelphia, Pennsylvania, 19103, United States

  • Palm Harbor Dermatology

    Tampa, Florida, 33609, United States

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 2217, Australia

  • Progressive Clinical Research, PA

    San Antonio, Texas, 78213, United States

  • Riverchase Dermatology

    Pembroke Pines, Florida, 33028, United States

  • Royal Infirmary of Edinburgh at Little France

    Edinburgh, EH16 4SA, United Kingdom

  • Rybear, Inc.

    Fort Lauderdale, Florida, 33316, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1, Canada

  • Skin Specialists, PC

    Omaha, Nebraska, 68144, United States

  • Somerset Skin Centre

    Troy, Michigan, 48084, United States

  • St. George Dermatology & Skin Cancer Centre

    Kogarah, New South Wales, 2217, Australia

  • Stratica Medical

    Edmonton, Alberta, T5K 1X3, Canada

  • Studienzentrale Entzündliche Hauterkrankungen

    Erlangen, 91054, Germany

  • Taipei Medical University Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 21431, South Korea

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • University Hospital Dresden

    Dresden, 01307, Germany

  • University Hospital Muenster, Department of Dermatology

    Münster, 48149, Germany

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Florida, Department of Dermatology

    Gainesville, Florida, 32610, United States

  • University of Miami Itch Center

    Miami, Florida, 33136, United States

  • University of Rochester Dermatology at College Town

    Rochester, New York, 14620, United States

  • Velocity Clinical Research - North Hollywood

    North Hollywood, California, 91606, United States

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102, Australia

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056, United States

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

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