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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety as assessed by the incidence and severity of adverse events
Secondary outcome measures
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
61 Previous Clinical Trials
3,905 Total Patients Enrolled
1 Trials studying Chronic Urticaria
208 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

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

Is enrollment open to individuals in the under 35 demographic for this research?

"This clinical trial has an age eligibility of 18 years or older and 75 years old or younger."

Answered by AI

Are participants still being accepted to join this research trial?

"The clinical trial hosted on clinicaltrials.gov is no longer recruiting participants, as the last edit to its page was made on August 31st 2022. Despite this being the case, there are still 36 other studies actively searching for patients at this current time."

Answered by AI

Am I qualified to partake in this research?

"This trial requires 40 participants aged between 18 and 75 who are currently suffering from urticaria. To qualify for the study, patients must have been using H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists over the past 3 days; possess no other medical issues which would cause further risk or hinder procedures; display itchiness and hives consistently for at least 6 weeks prior to Visit 1 despite current use of drugs; desire to finish a daily symptom electronic diary throughout the duration of treatment and be able to keep up with visit times; demonstrate an UAS"

Answered by AI

How many facilities are overseeing this clinical trial?

"At present, the enrolment process is occurring in 12 sites across America. These include Birmingham, Indianapolis and Tampa as well as other cities. To lessen travel needs if you choose to partake, pick a site that's nearest to your residence."

Answered by AI

What health risks might be posed by CDX-0159?

"Due to the limited data surrounding CDX-0159, our team at Power has assigned it a safety score of 1. This rating is because this trial only in its first phase and there's an absence of sufficient evidence demonstrating efficacy or security."

Answered by AI
~10 spots leftby Apr 2025