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Monoclonal Antibodies

Barzolvolimab 450 mg, then 150 mg Q4W 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)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor

61 Previous Clinical Trials

3,830 Total Patients Enrolled

1 Trials studying Prurigo Nodularis

24 Patients Enrolled for Prurigo Nodularis

Frequently Asked Questions

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

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"Indeed, according to the details on clinicaltrials.gov, this medical investigation is actively pursuing participants. The trial's initial posting was recorded on April 1st, 2024 and its latest update occurred on April 15th of the same year. A total of 120 individuals are sought for enrollment across two distinct sites."

Answered by AI

What is the overall count of participants involved in this clinical investigation?

"Affirmative. The details on clinicaltrials.gov specify that this investigation is actively seeking participants. Originally shared on April 1st, 2024, the trial was most recently revised on April 15th, 2024. A total of 120 volunteers are required across two designated locations for this research endeavor."

Answered by AI

Has the FDA granted approval for Barzolvolimab at doses of 450 mg followed by 150 mg every four weeks?

"With the ongoing Phase 2 trial of Barzolvolimab at doses of 450 mg followed by 150 mg every four weeks, our team has rated its safety as a level 2. This denotes that while some data indicates its safety profile, there is no evidence yet to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Barzolvolimab in Patients With Prurigo Nodularis

2024. "A Study of Barzolvolimab in Patients With Prurigo Nodularis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06366750.

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