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

Phase 2
Waitlist Available
Research Sponsored by Kiniksa Pharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8 (phase 2a); at week 16 (phase 2b)

Summary

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.

Eligible Conditions
  • Prurigo Nodularis
  • Itchiness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8 (phase 2a); at week 16 (phase 2b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 (phase 2a); at week 16 (phase 2b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
Secondary study objectives
*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS
Phase 2a: Change from baseline in 5-D Pruritus total score over time
Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time
+31 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vixarelimab
2019
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Kiniksa Pharmaceuticals, Ltd.Lead Sponsor
8 Previous Clinical Trials
1,242 Total Patients Enrolled
John Paolini, M.D.Study DirectorKiniksa Pharmaceuticals, Ltd.
2 Previous Clinical Trials
128 Total Patients Enrolled
~28 spots leftby Dec 2025
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