Active — Not RecruitingPhase 2

A Study of Barzolvolimab in Patients With Prurigo Nodularis

United States140 participantsStarted 2024-04-12

Plain-language summary

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and females, ≥18 years of age.
✓. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
✓. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
✓. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
✓. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
✓. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
✓. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
✓. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.

✕. PN due to neuropathy, psychiatric disorders or medications.
✕. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
✕. Active unstable pruritic skin conditions in addition to PN.
✕. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
✕. Females who are pregnant or nursing.
✕. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
✕. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
✕. History of anaphylaxis.

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

Timeframe: From Day 1 (first dose) to Day 85 (week 12)

NCT IDNCT06366750

SponsorCelldex Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and females, ≥18 years of age.
✓. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
✓. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
✓. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
✓. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
✓. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
✓. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
✓. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.

✕. PN due to neuropathy, psychiatric disorders or medications.
✕. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
✕. Active unstable pruritic skin conditions in addition to PN.
✕. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
✕. Females who are pregnant or nursing.
✕. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
✕. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
✕. History of anaphylaxis.