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apremilast

Generic: APREMILAST·Brand: APREMILAST, OTEZLA, OTEZLA XR, Otezla

apremilast: 10 clinical trials tracked.

apremilast evidence translation

What we can confirm

10 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about apremilast, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 5 study sponsors
Clinical Trials (10)

Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients

Not yet recruiting

Primary endpoint: Disease Activity Index for Psoriatic Arthritis

InterventionalRandomizeddouble60 targetStarted 2026-12Completion 2026-121 site · EgyptTanta University

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)

NCT06588738·Phase 3·ALMS
Completed

Primary endpoint: To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo

InterventionalRandomizedquadruple862 enrolledStarted 2024-08Completion 2025-1250 sites · Austria, Canada, United StatesAlumis Inc

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

NCT06586112·Phase 3·ALMS
Completed

Primary endpoint: To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo

InterventionalRandomizedquadruple912 enrolledStarted 2024-07Completion 2025-1150 sites · United StatesAlumis Inc

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

NCT06108544·Phase 3·TAK
Completed

Primary endpoint: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo

InterventionalRandomizedquadruple1,108 enrolledStarted 2023-11Completion 2025-1150 sites · United StatesTakeda

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

NCT06088043·Phase 3·TAK
Completed

Primary endpoint: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo

InterventionalRandomizedquadruple693 enrolledStarted 2023-11Completion 2025-1050 sites · Australia, Canada, China, United StatesTakeda

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

NCT06088199·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants With Treatment-emergent Adverse Events

Interventionalopen51 enrolledStarted 2023-10Completion 2026-0830 sites · United StatesAmgen

A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

NCT05565560·Phase 3·AMGN
Active, not recruiting

Primary endpoint: Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16

Interventionalopen17 enrolledStarted 2023-01Completion 2026-0929 sites · JapanAmgen

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

NCT04227314·Phase 3·CRNX
Recruiting

Primary endpoint: Presence of oral ulcer during clinical examination

InterventionalRandomizedtriple134 targetStarted 2022-04Completion 2026-1221 sites · FranceUniversity Hospital, Rouen

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

NCT04804553·Phase 3·AMGN
Recruiting

Primary endpoint: Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16

InterventionalRandomizedquadruple60 targetStarted 2022-03Completion 2028-1245 sites · Austria, Belgium, France, Germany…Amgen

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

NCT04528082·Phase 3·AMGN
Recruiting

Primary endpoint: Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12)

InterventionalRandomizedquadruple60 targetStarted 2021-09Completion 2030-1227 sites · France, Greece, Israel, Italy…Amgen