A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease

Conditions

• Behçet's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Tablets for oral administration
• Placebo — DRUG
  Tablets for oral administration

Study Details

The main objective of this study is to evaluate the efficacy and safety of apremilast in the treatment of oral ulcers in adults with active Behçet's disease (BD).

Key Dates

First listed

Dec 4, 2014

Start date

Dec 30, 2014

Status verified

Jul 2021

Primary completion

Sep 25, 2017

Completion

Jul 17, 2020

Study Design

Enrollment

207 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo / Apremilast
  Participants randomized to this arm will receive placebo tablets twice daily by mouth for the first twelve weeks followed by 52 weeks of 30 mg apremilast tablets twice daily by mouth.
• Experimental: Apremilast
  Participants randomized to this arm will receive 30 mg apremilast tablets twice daily by mouth for 64 weeks.

Primary Outcome Measure

Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) [ Time Frame: Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period. ]

Locations (11)

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