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Monoclonal Antibodies

CC-93538 for Atopic Dermatitis

Phase 2
Waitlist Available
Research Sponsored by Celgene
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 initial nrs pruritus response up to study day 127 (127 days)
Awards & highlights

Study Summary

This trial will study a new drug for Atopic Dermatitis in adults to see if it is effective and safe.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial nrs pruritus response up to study day 127 (127 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial nrs pruritus response up to study day 127 (127 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percentage Change From Baseline in EASI at Week 16
Secondary outcome measures
Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of Participants With Treatment Emergent Adverse Events
+9 more

Side effects data

From 2022 Phase 2 trial • 221 Patients • NCT04800315
37%
Dermatitis atopic
7%
COVID-19
7%
Upper respiratory tract infection
7%
Conjunctivitis allergic
6%
Fatigue
6%
Blood creatine phosphokinase increased
6%
Folliculitis
6%
Alanine aminotransferase increased
4%
Headache
4%
Nasopharyngitis
4%
Back pain
2%
Respiratory tract infection
2%
Injection site erythema
2%
Cellulitis
2%
Deep vein thrombosis
2%
Pulmonary hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 1
Treatment 2
Treatment 3
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 3: CC-93538 SC Q2W and Placebo SC weeklyExperimental Treatment2 Interventions
Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.
Group II: Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2WExperimental Treatment2 Interventions
Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Group III: Dose 1: CC-93538 SC QWExperimental Treatment1 Intervention
Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Group IV: Placebo SC QWPlacebo Group1 Intervention
Administration of placebo each week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-93538
2021
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
633 Previous Clinical Trials
127,821 Total Patients Enrolled
Steven Draikiwicz, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,502 Previous Clinical Trials
3,367,473 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?
Alabama
California
How old are they?
18 - 65
What site did they apply to?
Local Institution - 114
Local Institution - 105
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
2021. "A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800315.
~56 spots leftby Apr 2025
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