Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

NCT ID: NCT03816891

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2023-08-24

Brief Summary

Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).

Detailed Description

This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus.

Phase 2a portion:

Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus are treated in the Phase 2a portion of the study. At Baseline, subjects are randomized 1:1 to receive double-blind (DBL) vixarelimab or placebo: vixarelimab 720 mg loading dose followed by 360 mg every week; placebo loading dose followed by placebo every week. The treatment period is 8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol amendment [Protocol Version 3]).

Phase 2b portion:

The Phase 2b study consists of a 4-week Screening Period and a 16-week Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately 180 subjects with PN, experiencing severe pruritus, are randomized (at 1:1:1:1 ratio) into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug are administered during the Double-Blind Period to measure the efficacy, safety, and PK of Vixarelimab. After the Double-Blind Period, all subjects have the option to receive vixarelimab during the OLE Period to evaluate the long-term safety and PK.

Conditions

Prurigo Nodularis; Pruritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 2a - Vixarelimab 360 mg SC Weekly (QW)

Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Group Type: EXPERIMENTAL

Vixarelimab

Intervention Type: DRUG

solution for injection

Phase 2a - Placebo SC QW

Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

solution for injection

Phase 2b - Vixarelimab 540 mg SC Every 4 Weeks (Q4W; DBL)

Vixarelimab 540 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Group Type: EXPERIMENTAL

Vixarelimab

Intervention Type: DRUG

solution for injection

Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)

Vixarelimab 360 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Group Type: EXPERIMENTAL

Vixarelimab

Intervention Type: DRUG

solution for injection

Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)

Vixarelimab 120 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Group Type: EXPERIMENTAL

Vixarelimab

Intervention Type: DRUG

solution for injection

Phase 2b - Placebo SC, Q4W (DBL)

Placebo SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

solution for injection

Phase 2b - Vixarelimab 360 mg SC, Every 2 Weeks (Q2W; OLE)

Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension

Group Type: EXPERIMENTAL

Vixarelimab

Intervention Type: DRUG

solution for injection

Interventions

Vixarelimab

solution for injection

Intervention Type: DRUG

Placebo

solution for injection

Intervention Type: DRUG

Other Intervention Names

KPL-716; RG6536

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kiniksa Pharmaceuticals, Ltd.

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Arizona Research Center

Phoenix, Arizona, United States

Investigate MD, LLC

Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

First OC Dermatology

Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Wallace Medical Group, Inc.

Los Angeles, California, United States

Velocity Clinical Research - North Hollywood

North Hollywood, California, United States

Colorado Center for Dermatology, PLLC

Centennial, Colorado, United States

George Washington University Medical Faculty Associates

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

Rybear, Inc.

Fort Lauderdale, Florida, United States

University of Florida, Department of Dermatology

Gainesville, Florida, United States

Olympian Clinical Research

Largo, Florida, United States

University of Miami Itch Center

Miami, Florida, United States

Riverchase Dermatology

Pembroke Pines, Florida, United States

Olympian Clinical Research

St. Petersburg, Florida, United States

Advanced Clinical Research Institute

Tampa, Florida, United States

Palm Harbor Dermatology

Tampa, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Alliance Clinical Research of Tampa

Tampa, Florida, United States

Integrated Clinical Research

West Palm Beach, Florida, United States

Advanced Medical Research PC

Sandy Springs, Georgia, United States

DS Research

New Albany, Indiana, United States

DS Research

Louisville, Kentucky, United States

ALLCUTIS Research, LLC

Beverly, Massachusetts, United States

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Grekin Skin Institute

Warren, Michigan, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Bobby Buka MD, PC

New York, New York, United States

University of Rochester Dermatology at College Town

Rochester, New York, United States

Wright State Physicians

Fairborn, Ohio, United States

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, United States

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

Charleston, South Carolina, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Progressive Clinical Research, PA

San Antonio, Texas, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

St. George Dermatology & Skin Cancer Centre

Kogarah, New South Wales, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Medical University of Graz

Graz, , Austria

Medical University of Vienna

Vienna, , Austria

Cliniques Universitaires Saint-Luc (UCL St-Luc)

Brussels, , Belgium

CHU de Liège

Liège, , Belgium

Stratica Medical

Edmonton, Alberta, Canada

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

Central Alberta Research Clinic (CARe Clinic)

Red Deer, Alberta, Canada

Brunswick Dermatology Center

Fredericton, New Brunswick, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

Drc Angélique Gagné-Henley MD Inc.

Saint-Jérôme, Quebec, Canada

CCR Czech a.s.

Pardubice, , Czechia

CLINTRIAL s.r.o.

Prague, , Czechia

Hôpital Saint André - CHU de Bordeaux

Bordeaux, , France

Hôpital Morvan - CHU Brest

Brest, , France

CHU Nantes - Service de Dermatologie

Nantes, , France

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

Klinikum Bielefeld Rosenhöhe

Bielefeld, North Rhine-Westphalia, Germany

University Hospital Dresden

Dresden, , Germany

Studienzentrale Entzündliche Hauterkrankungen

Erlangen, , Germany

George-August-Universität Göttingen

Göttingen, , Germany

University Hospital Muenster, Department of Dermatology

Münster, , Germany

Eberhard-Karls-University

Tübingen, , Germany

Hautarztpraxis Dr. Hoffmann

Witten, , Germany

A.O.U. Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Asst Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, , Italy

Grażyna Pulka Centrum Medyczne All-Med

Krakow, , Poland

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

Rzeszów, , Poland

Kyclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, , Poland

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

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

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

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Royal Infirmary of Edinburgh at Little France

Edinburgh, , United Kingdom

Barts Health NHS Trust, Whipps Cross Hospital

Leytonstone, , United Kingdom

Broadgreen Hospital

Liverpool, , United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; France; Germany; Italy; Poland; South Korea; Taiwan; United Kingdom

References

Stander S, Yosipovitch G, Sofen H, Abramzon D, Galanter J, Wang S, Paolini JF. Vixarelimab in Patients With Prurigo Nodularis: A Randomized Clinical Trial. JAMA Dermatol. 2025 Dec 17. doi: 10.1001/jamadermatol.2025.4950. Online ahead of print.

Reference Type: DERIVED

PMID: 41405882 (View on PubMed)

Ma DX, Neerumalla S, Baird A, Whitehead RA, Filip P, Tajudeen BA, Batra PS, Papagiannopoulos P. Impact of Obesity on the Structured Histopathology of Chronic Rhinosinusitis Patients. Laryngoscope. 2025 Oct 6. doi: 10.1002/lary.70177. Online ahead of print.

Reference Type: DERIVED

PMID: 41051123 (View on PubMed)

Sofen H, Bissonnette R, Yosipovitch G, Silverberg JI, Tyring S, Loo WJ, Zook M, Lee M, Zou L, Jiang GL, Paolini JF. Efficacy and safety of vixarelimab, a human monoclonal oncostatin M receptor beta antibody, in moderate-to-severe prurigo nodularis: a randomised, double-blind, placebo-controlled, phase 2a study. EClinicalMedicine. 2023 Feb 3;57:101826. doi: 10.1016/j.eclinm.2023.101826. eCollection 2023 Mar.

Reference Type: DERIVED

PMID: 36816342 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Phase 2a Protocol

View Document

Document Type: Study Protocol: Phase 2b Protocol

View Document

Document Type: Statistical Analysis Plan: Phase 2a SAP

View Document

Document Type: Statistical Analysis Plan: Phase 2b SAP

View Document

Other Identifiers

GS45044

Identifier Type: OTHER

Identifier Source: secondary_id

KPL-716-C201

Identifier Type: -

Identifier Source: org_study_id