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NCT03123471 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

A Phase 3 study of Psoriasis, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
303
Enrollment target
20
Study locations

NCT03123471 is a Phase 3 study of Psoriasis that has completed, run by Amgen. The registered enrollment target is 303 participants, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03123471, a Phase 3 study of Psoriasis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
303 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Apremilast

Study Locations (20)

California

  • Tien Q. Nguyen MD Inc - Fountain Valley
  • Dermatology Research Associates - Los Angeles
  • San Luis Dermatology and Laser Clinic - San Luis Obispo

Florida

  • Florida Academic Centers Research and Education - Coral Gables
  • International Dermatology Research - Miami
  • Renstar Medical Research - Ocala

Georgia

  • Dermatologic Surgery Specialists, P.C. - Macon
  • MedaPhase INC - Newnan

Kentucky

  • DS Research - Louisville
  • DS Research - Louisville

New York

  • SUNY Downstate Medical Center - Brooklyn
  • Forest Hills Dermatology Group - Forest Hills

Arkansas

  • Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology - Rogers

Connecticut

  • University of Connecticut - Farmington

Indiana

  • The Indiana Clinical Trials Center, PC - Plainfield

Trial Details

FieldValue
Enrollment Target 303 participants
Start Date 2017-05-16
Est. Completion 2019-01-09
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT03123471

The ClinicalTrials.gov registry entry for NCT03123471 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (38% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03123471 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT03123471 about?

NCT03123471 is a clinical study titled "A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp". This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomiz...

What is the current status of trial NCT03123471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2017-05-16. Estimated completion is 2019-01-09.

What conditions does trial NCT03123471 study?

This clinical trial studies the following conditions: Psoriasis.

What interventions are being tested in trial NCT03123471?

The interventions under investigation include: Placebo (OTHER), Apremilast (DRUG).

Who is sponsoring clinical trial NCT03123471?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03123471 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.