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

NCT03816891 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: KPL-716-C201GS45044
• Study Type: interventional
• Target: 240
• Locations: 12 countries
• Sites: 84

Brief Summary

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

Conditions

Prurigo Nodularis; Pruritis

Outcome Measures

Primary Outcomes (1)

• Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score

  Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.

  at Week 8 (Phase 2a); at Week 16 (Phase 2b)

Secondary Outcomes (38)

• Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8

  Baseline, Week 8

• Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8

  Baseline, Week 8

• Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time

  Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

• Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time

  Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

• Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time

  Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24

Study Arms (7)

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

EXPERIMENTAL

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

Drug: Vixarelimab

Phase 2a - Placebo SC QW

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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

Drug: Vixarelimab

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

EXPERIMENTAL

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

Drug: Vixarelimab

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

EXPERIMENTAL

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

Drug: Vixarelimab

Phase 2b - Placebo SC, Q4W (DBL)

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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

Drug: Vixarelimab

Interventions

Vixarelimab DRUG

solution for injection

Also known as: KPL-716, RG6536

Phase 2a - Vixarelimab 360 mg SC Weekly (QW); Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL); Phase 2b - Vixarelimab 360 mg SC, Every 2 Weeks (Q2W; OLE); Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL); Phase 2b - Vixarelimab 540 mg SC Every 4 Weeks (Q4W; DBL)

Placebo DRUG

solution for injection

Phase 2a - Placebo SC QW; Phase 2b - Placebo SC, Q4W (DBL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)
• Have clinical diagnosis of prurigo nodularis for at least 6 months
• Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1
• Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)
• 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
• 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

You may not qualify if:

• Use of prohibited medications within the indicated timeframe from Day 1
• Is currently using medication known to cause pruritus
• 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
• Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
• Has an active infection, including skin infection
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• Kiniksa Pharmaceuticals, Ltd.: collaborator

Study Sites (86)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Wallace Medical Group, Inc.

Los Angeles, California, 90056, United States

Location

Velocity Clinical Research - North Hollywood

North Hollywood, California, 91606, United States

Location

Colorado Center for Dermatology, PLLC

Centennial, Colorado, 80111, United States

Location

George Washington University Medical Faculty Associates

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

Location

Rybear, Inc.

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida, Department of Dermatology

Gainesville, Florida, 32610, United States

Location

Olympian Clinical Research

Largo, Florida, 33770, United States

Location

University of Miami Itch Center

Miami, Florida, 33136, United States

Location

Riverchase Dermatology

Pembroke Pines, Florida, 33028, United States

Location

Olympian Clinical Research

St. Petersburg, Florida, 33709, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Palm Harbor Dermatology

Tampa, Florida, 33609, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Integrated Clinical Research

West Palm Beach, Florida, 33406, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

ALLCUTIS Research, LLC

Beverly, Massachusetts, 01915, United States

Location

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Grekin Skin Institute

Warren, Michigan, 08088, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Bobby Buka MD, PC

New York, New York, 10012, United States

Location

University of Rochester Dermatology at College Town

Rochester, New York, 14620, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

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

Charleston, South Carolina, 29425, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

St. George Dermatology & Skin Cancer Centre

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Medical University of Graz

Graz, 8036, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Cliniques Universitaires Saint-Luc (UCL St-Luc)

Brussels, 1200, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

Location

Central Alberta Research Clinic (CARe Clinic)

Red Deer, Alberta, T4N6V7, Canada

Location

Brunswick Dermatology Center

Fredericton, New Brunswick, E3B 1G9, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

Drc Angélique Gagné-Henley MD Inc.

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

CCR Czech a.s.

Pardubice, 53 002, Czechia

Location

CLINTRIAL s.r.o.

Prague, 10000, Czechia

Location

Hôpital Saint André - CHU de Bordeaux

Bordeaux, 33075, France

Location

Hôpital Morvan - CHU Brest

Brest, 29609, France

Location

CHU Nantes - Service de Dermatologie

Nantes, 44093, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Klinikum Bielefeld Rosenhöhe

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Studienzentrale Entzündliche Hauterkrankungen

Erlangen, 91054, Germany

Location

George-August-Universität Göttingen

Göttingen, 37075, Germany

Location

University Hospital Muenster, Department of Dermatology

Münster, 48149, Germany

Location

Eberhard-Karls-University

Tübingen, 72076, Germany

Location

Hautarztpraxis Dr. Hoffmann

Witten, 58453, Germany

Location

A.O.U. Policlinico Vittorio Emanuele

Catania, Sicily, 95123, Italy

Location

Asst Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Grażyna Pulka Centrum Medyczne All-Med

Krakow, 30-033, Poland

Location

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

Rzeszów, 35-055, Poland

Location

Kyclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, 50-367, Poland

Location

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

Incheon, 21431, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

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

New Taipei City, 23561, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Royal Infirmary of Edinburgh at Little France

Edinburgh, EH16 4SA, United Kingdom

Location

Barts Health NHS Trust, Whipps Cross Hospital

Leytonstone, E11 1NR, United Kingdom

Location

Broadgreen Hospital

Liverpool, L14 3AB, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• 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. 2026 Feb 1;162(2):133-141. doi: 10.1001/jamadermatol.2025.4950.

  PMID: 41405882 DERIVED

• 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. 2026 Mar;136(3):1150-1157. doi: 10.1002/lary.70177. Epub 2025 Oct 6.

  PMID: 41051123 DERIVED

• 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.

  PMID: 36816342 DERIVED

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2a: 2 arms; Phase 2b: 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: March 11, 2019
• Primary Completion: December 28, 2022
• Study Completion: August 24, 2023
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-01

Locations

US (40); CZ (2); IT (2); PL (3); KR (4); CA (8); BE (2); TW (4); FR (3); DE (8); AU (4); GB (4)