Barzolvolimab for Prurigo Nodularis

Phase 2

Recruiting

Research Sponsored by Celldex Therapeutics

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 from day 1 (first dose) to day 169 (week 24)

Summary

This trial aims to investigate whether barzolvolimab is effective and safe in treating adults with prurigo nodularis.

Who is the study for?

This clinical trial is for adults with prurigo nodularis, a skin condition characterized by itchy lumps. Participants should meet specific health criteria set by the study's guidelines.

What is being tested?

The trial is testing barzolvolimab against a placebo to see if it can effectively and safely treat prurigo nodularis. Patients will be randomly assigned to receive either the actual drug or a placebo.

What are the potential side effects?

Potential side effects of barzolvolimab may include reactions at the injection site, general discomfort, or other immune-related responses due to its action on the body's immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 (first dose) to day 169 (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 (first dose) to day 169 (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (first dose) to day 169 (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.

Secondary study objectives

Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.

Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD.

Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24.

+21 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Barzolvolimab 450 mg, then 300 mg Q4WExperimental Treatment1 Intervention

450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Group II: Barzolvolimab 450 mg, then 150 mg Q4WExperimental Treatment1 Intervention

450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Group III: PlaceboPlacebo Group1 Intervention

Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

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