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Monoclonal Antibodies

Apremilast for Atopic Dermatitis

Phase 2
Waitlist Available
Led By David Rosmarin, MD
Research Sponsored by Tufts Medical Center
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 24 weeks
Awards & highlights

Study Summary

This trial is testing whether the drug apremilast can improve the effectiveness of the existing drug dupilumab for treating atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients Who Achieve an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.
Secondary outcome measures
Body Surface Area (BSA) Involvement
Dermatology Life Quality Index (DLQI) Score
Eczema Area and Severity Index (EASI) Score
+2 more
Other outcome measures
Safety Analysis

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
right flank pain
5%
abscess right hand
5%
cyst left inner thigh
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApremilastExperimental Treatment1 Intervention
Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2300

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,727 Total Patients Enrolled
AmgenIndustry Sponsor
1,380 Previous Clinical Trials
1,379,611 Total Patients Enrolled
David Rosmarin, MDPrincipal InvestigatorTufts Medical Center
4 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab
2020. "Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04306965.
~2 spots leftby May 2025
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