A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Celldex Therapeutics
- Enrollment
- 208
- Locations
- 56
- Primary Endpoint
- Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Study Overview
Brief Summary
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria
Detailed Description
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria.
There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
barzolvolimab 75 mg then 150 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
Intervention: barzolvolimab (Biological)
barzolvolimab 75 mg then 300 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
Intervention: barzolvolimab (Biological)
barzolvolimab 150 mg
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
Intervention: barzolvolimab (Biological)
barzolvolimab 300 mg
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
Intervention: barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
Intervention: barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
Intervention: Matching Placebo (Drug)
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
Intervention: barzolvolimab (Biological)
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
Intervention: Matching Placebo (Drug)
Outcomes
Primary Outcomes
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Time Frame: From baseline to Day 85 (Week 12)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None 1. = mild (present, but not annoying or troublesome) 2. = moderate (troublesome, but does not interfere with normal daily activity or sleep) 3. = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None 1. = less than 20 hives 2. = between 20 and 50 hives 3. = greater than 50 hives
Secondary Outcomes
- Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)(From baseline to Day 85 (Week 12))
- Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)(From baseline to Day 85 (Week 12))
- Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)(From baseline to Day 85 (Week 12))