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Phosphodiesterase 4 (PDE4) Inhibitor

Extension Phase: Apremilast 30 mg for Psoriasis (ADVANCE Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
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 placebo: day 1 to week 16; apremilast day 1 to a maximum of week 32 (plus 4 week safety follow-up)
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Eligible Conditions
  • Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~placebo: day 1 to week 16; apremilast day 1 to a maximum of week 32 (plus 4 week safety follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and placebo: day 1 to week 16; apremilast day 1 to a maximum of week 32 (plus 4 week safety follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
Secondary study objectives
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Change From Baseline in Percentage of Affected BSA at Week 16
Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Placebo-controlled Phase: Apremilast 30 mgExperimental Treatment1 Intervention
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
Group II: Placebo-controlled Phase:Experimental Treatment1 Intervention
Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
Group III: Extension Phase: Apremilast 30 mgExperimental Treatment1 Intervention
Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
FDA approved

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,429 Previous Clinical Trials
1,384,190 Total Patients Enrolled
76 Trials studying Psoriasis
115,915 Patients Enrolled for Psoriasis
MDStudy DirectorAmgen
969 Previous Clinical Trials
928,518 Total Patients Enrolled
64 Trials studying Psoriasis
22,725 Patients Enrolled for Psoriasis
~90 spots leftby Oct 2025
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