Status:
COMPLETED
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Kiniksa Pharmaceuticals, Ltd.
Conditions:
Prurigo Nodularis
Pruritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 subj...
Eligibility Criteria
Inclusion
- Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):
- 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
- Exclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):
- 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
Exclusion
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03816891
Start Date
March 11 2019
End Date
August 24 2023
Last Update
June 4 2025
Active Locations (86)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Investigate MD, LLC
Scottsdale, Arizona, United States, 85255
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
First OC Dermatology
Fountain Valley, California, United States, 92708