Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Launched by GENENTECH, INC. · Jan 23, 2019
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- 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
About Genentech, Inc.
Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Little Rock, Arkansas, United States
Lebanon, New Hampshire, United States
Parkville, Victoria, Australia
Washington, District Of Columbia, United States
Troy, Michigan, United States
Seoul, , Korea, Republic Of
Dresden, , Germany
Omaha, Nebraska, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
Seoul, , Korea, Republic Of
Wien, , Austria
Graz, , Austria
Edmonton, Alberta, Canada
Fort Gratiot, Michigan, United States
Markham, Ontario, Canada
Seoul, , Korea, Republic Of
Clinton Township, Michigan, United States
Bad Bentheim, Niedersachsen, Germany
Liège, , Belgium
Taipei, , Taiwan
Fremont, California, United States
Phoenix, Arizona, United States
Southampton, , United Kingdom
Pflugerville, Texas, United States
Tampa, Florida, United States
Methuen, Massachusetts, United States
Woolloongabba, Queensland, Australia
San Antonio, Texas, United States
Barrie, Ontario, Canada
Louisville, Kentucky, United States
Incheon, , Korea, Republic Of
Praha 10, , Czechia
Fairborn, Ohio, United States
Fountain Valley, California, United States
Largo, Florida, United States
New Albany, Indiana, United States
Taipei, Ntaiwan, Taiwan
Spokane, Washington, United States
West Palm Beach, Florida, United States
Edmonton, Alberta, Canada
London, Ontario, Canada
Los Angeles, California, United States
Taoyuan City, , Taiwan
Tampa, Florida, United States
Sandy Springs, Georgia, United States
Kogarah, New South Wales, Australia
Anniston, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Colton, California, United States
Fountain Valley, California, United States
Fremont, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
North Hollywood, California, United States
San Francisco, California, United States
Centennial, Colorado, United States
Washington, District Of Columbia, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Largo, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Sandy Springs, Georgia, United States
Boise, Idaho, United States
Downers Grove, Illinois, United States
New Albany, Indiana, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Beverly, Massachusetts, United States
Clinton Township, Michigan, United States
Fort Gratiot, Michigan, United States
Troy, Michigan, United States
Warren, Michigan, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Rochester, New York, United States
Fairborn, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Pflugerville, Texas, United States
San Antonio, Texas, United States
Spokane, Washington, United States
Kogarah, New South Wales, Australia
Kogarah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Parkville, Victoria, Australia
Graz, , Austria
Wien, , Austria
Brussels, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Red Deer, Alberta, Canada
Fredericton, New Brunswick, Canada
Barrie, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Saint Jérôme, Quebec, Canada
Pardubice, , Czechia
Praha 10, , Czechia
Bordeaux, , France
Brest, , France
Nantes, , France
Paris, , France
Toulouse, , France
Bad Bentheim, Niedersachsen, Germany
Bielefeld, Nrw, Germany
Erlangen, , Germany
Münster, , Germany
Witten, , Germany
Catania, Sicily, Italy
Brescia, , Italy
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kraków, , Poland
Kraków, , Poland
Rzeszów, , Poland
Wrocław, , Poland
New Taipei City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan City, , Taiwan
Liverpool, , United Kingdom
Southampton, , United Kingdom
Scottsdale, Arizona, United States
Fredericton, New Brunswick, Canada
Tampa, Florida, United States
New York, New York, United States
North Hollywood, California, United States
Beverly, Massachusetts, United States
Witten, , Germany
Dresden, , Germany
Göttingen, , Germany
Leytonstone, , United Kingdom
Saint Petersburg, Florida, United States
Pembroke Pines, Florida, United States
Miami, Florida, United States
Centennial, Colorado, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Warren, Michigan, United States
Rochester, New York, United States
Charleston, South Carolina, United States
Kogarah, New South Wales, Australia
Brussels, , Belgium
Red Deer, Alberta, Canada
Saint Jérôme, Quebec, Canada
Pardubice, , Czechia
Bordeaux, , France
Brest, , France
Nantes, , France
Bielefeld, Nrw, Germany
Erlangen, , Germany
Göttingen, , Germany
Münster, , Germany
Tübingen, , Germany
Catania, Sicily, Italy
Brescia, , Italy
Kraków, , Poland
Rzeszów, , Poland
Wrocław, , Poland
New Taipei City, , Taiwan
Edinburgh, , United Kingdom
Leytonstone, , United Kingdom
Liverpool, , United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Genentech, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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