Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Recruiting in Palo Alto (17 mi)
+90 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Kiniksa Pharmaceuticals, Ltd.
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing Vixarelimab, an injectable medication, in patients with prurigo nodularis who suffer from severe itching. The medication works by calming the immune system to reduce inflammation and itching.
Eligibility Criteria
Inclusion Criteria
Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)
Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1
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
+3 more
Exclusion Criteria
Use of prohibited medications within the indicated timeframe from Day 1
Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
Has an active infection, including skin infection
+3 more
Participant Groups
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)Experimental Treatment1 Intervention
Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Group II: Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)Experimental Treatment1 Intervention
Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Group III: Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)Experimental Treatment1 Intervention
Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension
Group IV: Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)Experimental Treatment1 Intervention
Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Group V: Phase 2a - Vixarelimab 360 mg SC QWExperimental Treatment1 Intervention
Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
Group VI: Phase 2a - Placebo SC QWPlacebo Group1 Intervention
Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
Group VII: Phase 2b - Placebo SC, Q4W (DBL)Placebo Group1 Intervention
Placebo SC, every 4 weeks for 16 weeks during Double Blind Period
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site 1138Baton Rouge, LA
Site 1135Miami, FL
Site 123New Albany, IN
Site 1308Edmonton, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Kiniksa Pharmaceuticals, Ltd.Lead Sponsor