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vixarelimab for 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
Have clinical diagnosis of prurigo nodularis for at least 6 months
Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8 (phase 2a); at week 16 (phase 2b)
Awards & highlights

Study Summary

This trial is studying Vixarelimab to see if it is effective, safe, and tolerated in people with prurigo nodularis.

Eligible Conditions
  • Prurigo Nodularis
  • Itchiness

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with prurigo nodularis for at least 6 months.
Select...
You have moderate to severe itching (Phase 2a) or severe itching (Phase 2b).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
Secondary outcome measures
*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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular test subjects to patients who are over 30 years old?

"The age requirements to join this study are between 18 and 80 years old."

Answered by AI

Are there any patients required for this research project?

"While this trial is not recruiting patients at the current moment, that may change in the future. According to clinicaltrials.gov, which last updated information on this study on September 26th, 2022, this research was first posted March 11st, 2019. There are other medical trials currently enrolling patients however; 39 in total."

Answered by AI

Can you tell us about other times vixarelimab has been tested in a medical setting?

"vixarelimab was first studied at Site 1138 in 2019. Since then, there have been 18290 completed trials worldwide. Currently, 1 trial is still active and many of these studies are conducted in Fairborn, Ohio."

Answered by AI

Might I be eligible to take part in this clinical trial?

"The itchiness of the skin is a requisite for any would-be participant and they must also fall in the age bracket of 18 to 80. Currently, this study requires 190 individuals."

Answered by AI

Is this a novel clinical trial?

"Vixarelimab has been under investigation since 2019, when the first clinical trial was conducted by Kiniksa Pharmaceuticals. This initial study included 190 participants. Vixarelimab completed Phase 2 drug approval in 2019 and is only being studied in one active trial today, sponsored again by Kiniksa Pharmaceuticals."

Answered by AI

In how many distinct locations is this trial being conducted?

"This study has many locations with Site 1121 in Fairborn, Site 1167 in Los Angeles, and Site 1118 in Troy being a few of the available 35 options."

Answered by AI

Can you please give an overview of the risks associated with vixarelimab?

"While there is some data indicating that vixarelimab is safe, as this is only a Phase 2 trial, we at Power score its safety at a 2."

Answered by AI
~32 spots leftby Mar 2025