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Monoclonal Antibodies

CDX-0159 for Prurigo Nodularis

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 57 (week 8)
Awards & highlights

Study Summary

This trial is studying the effects of CDX-0159 on patients with a skin condition called Prurigo Nodularis.

Eligible Conditions
  • Prurigo Nodularis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (first dose) to day 57 (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (first dose) to day 57 (week 8) 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 and tolerability as assessed by the incidence and severity of adverse events
Secondary outcome measures
Clinical effect of CDX-0159 on pruritus
Pharmacokinetic evaluation

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CDX-0159 3mg/kgExperimental Treatment2 Interventions
CDX-0159 3.0 mg/kg administered once
Group II: CDX-0159 1.5mg/kgExperimental Treatment1 Intervention
CDX-0159 1.5mg/kg administered once
Group III: PlaceboPlacebo Group1 Intervention
Normal saline administered once
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal saline
2013
Completed Phase 4
~2090
CDX-0159
2021
Completed Phase 1
~180

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
60 Previous Clinical Trials
3,806 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
Florida
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of CDX-0159 in Patients With Prurigo Nodularis
2021. "A Study of CDX-0159 in Patients With Prurigo Nodularis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04944862.
~7 spots leftby Apr 2025
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