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Monoclonal Antibodies

CDX-0159 for Chronic Urticaria

Phase 1
Waitlist Available
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 (last follow-up visit)
Awards & highlights

Summary

This trial will test the safety of CDX-0159, given in multiple doses, to patients with a history of chronic hives with no known cause.

Eligible Conditions
  • Chronic Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (first dose) to day 169 (last follow-up visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (first dose) to day 169 (last follow-up visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as assessed by the incidence and severity of adverse events
Secondary study objectives
Pharmacodynamic evaluation
Pharmacokinetic evaluation
Safety evaluation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CDX-0159Experimental Treatment1 Intervention
CDX-0159 every 4-8 weeks
Group II: Normal SalinePlacebo Group1 Intervention
Normal saline every 4-8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-0159
2021
Completed Phase 1
~180

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
63 Previous Clinical Trials
5,724 Total Patients Enrolled
3 Trials studying Chronic Urticaria
2,038 Patients Enrolled for Chronic Urticaria
~9 spots leftby Sep 2025
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