Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Celldex Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: barzolvolimab; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07256392

CDX0159-17

Details and patient eligibility

About

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.

This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Full description

This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials.

The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater.

Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).

Enrollment: 1,370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Written informed consent
2. Must have completed 52 weeks of treatment and the 16-week follow up in either the CDX0159-12 or CDX0159-13successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
3. Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
4. Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.

Key Exclusion Criteria:

1. Active pruritic skin condition in addition to CSU.
2. Medical condition that would cause additional risk or interfere with study procedures.
3. Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,370 participants in 2 patient groups

Group 1 Observation Group

Experimental group

Description:

Standard of care treatment (at least 2nd generation Type 1 antihistamines \[H1AH\] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks.

Treatment:

Other: Standard of Care

Biological: barzolvolimab

Group 2 Barzolvolimab Retreatment Group

Experimental group

Description:

Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks

Treatment:

Biological: barzolvolimab