Apremilast

Generic Name: Apremilast

Brand Names: Otezla, Apremilast Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₄N_₂O_₇S

CAS Number: 608141-41-9

Unique Ingredient Identifier: UP7QBP99PN

Background: Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as Roflumilast and Crisaborole. Initially approved in 2014, it is marketed by Celgene. In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.

Indication: Apremilast is indicated for the treatment of adults with active psoriatic arthritis and adults with oral ulcers associated with Behcet's Disease. In addition, apremilast is indicated for the treatment of plaque psoriasis, of any severity, in adult patients who are candidates for phototherapy or systemic therapy.

Associated Conditions: Psoriasis Vulgaris (Plaque Psoriasis), Active Psoriatic arthritis, Ulceration of the mouth

Associated Therapies: -

Clinical Trials

Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

Not yet recruiting

Conditions: Psoriasis

Interventions: Drug: Apremilast

First Posted Date: 2023-05-18

Last Posted Date: 2023-05-18

Lead Sponsor: First Hospital of China Medical University

Target Recruit Count: 360

Registration Number: NCT05863273

Locations: 🇨🇳
China-Japan Friendship Hospital, Beijing, China
🇨🇳
the First Hospital of China Medical University, Shenyang, China

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Phase 3

Recruiting

Conditions: Behçet's Disease
Juvenile Psoriatic Arthritis

Interventions: Drug: Apremilast

First Posted Date: 2023-03-14

Last Posted Date: 2024-12-16

Lead Sponsor: Amgen

Target Recruit Count: 48

Registration Number: NCT05767047

Locations: 🇮🇱
Meir Medical Center, Kfar Saba, Israel
🇬🇷
General Hospital of Thessaloniki Ippokrateio, Thessaloniki, Greece
🇪🇸
Hospital Universitari i Politecnic La Fe, Valencia, Comunidad Valenciana, Spain

and more 3 locations

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Recruiting

Conditions: Psoriasis

Interventions: Drug: Apremilast
Drug: Deucravacitinib

First Posted Date: 2023-02-27

Last Posted Date: 2024-07-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1500

Registration Number: NCT05744466

Locations: 🇺🇸
Local Institution, Waltham, Massachusetts, United States

[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

Phase 1

Recruiting

Conditions: Depression

Interventions: Radiation: Lung scan
Drug: Apremilast
Drug: 18F-PF-06445974

First Posted Date: 2023-01-30

Last Posted Date: 2024-12-27

Lead Sponsor: National Institute of Mental Health (NIMH)

Target Recruit Count: 108

Registration Number: NCT05703685

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Apremilast

First Posted Date: 2022-10-04

Last Posted Date: 2025-01-03

Lead Sponsor: Amgen

Target Recruit Count: 33

Registration Number: NCT05565560

Locations: 🇯🇵
Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan
🇯🇵
Nagoya City University Hospital, Nagoya-shi, Aichi, Japan
🇯🇵
Fukuoka University Hospital, Fukuoka-shi, Fukuoka, Japan

and more 25 locations

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

Phase 3

Completed

Conditions: Palmoplantar Pustulosis

Interventions: Drug: Apremilast
Drug: Placebo

First Posted Date: 2021-12-30

Last Posted Date: 2024-11-05

Lead Sponsor: Amgen

Target Recruit Count: 176

Registration Number: NCT05174065

Locations: 🇯🇵
Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
🇯🇵
Seibo International Catholic Hospital, Shinjuku-ku, Tokyo, Japan
🇯🇵
Medical corporation kojinkai Chitose dermatology and plastic surgery clinic, Chitose-shi, Hokkaido, Japan

and more 37 locations

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Phase 4

Completed

Conditions: Psoriasis

Interventions: Drug: Risankizumab
Drug: Apremilast

First Posted Date: 2021-06-01

Last Posted Date: 2024-04-30

Lead Sponsor: AbbVie

Target Recruit Count: 352

Registration Number: NCT04908475

Locations: 🇺🇸
Epiphany Dermatology of Kansas LLC /ID# 229221, Overland Park, Kansas, United States
🇺🇸
Center for Clinical Studies - Houston (Binz) /ID# 229272, Houston, Texas, United States
🇺🇸
UC Davis Health /ID# 229133, Sacramento, California, United States

and more 51 locations

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Phase 3

Active, not recruiting

Conditions: Psoriatic Arthritis

Interventions: Drug: Deucravacitinib
Drug: Apremilast
Other: Placebo

First Posted Date: 2021-06-01

Last Posted Date: 2024-11-01

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 729

Registration Number: NCT04908189

Locations: 🇦🇷
Local Institution - 0200, Buenos Aires, Argentina
🇦🇺
Local Institution - 0018, Paramatta, New South Wales, Australia
🇦🇺
Local Institution - 0002, Camberwell, Victoria, Australia

and more 144 locations

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Phase 3

Recruiting

Conditions: Active Juvenile Psoriatic Arthritis

Interventions: Drug: Apremilast
Drug: Placebo

First Posted Date: 2021-03-18

Last Posted Date: 2025-01-03

Lead Sponsor: Amgen

Target Recruit Count: 60

Registration Number: NCT04804553

Locations: 🇦🇹
Landeskrankenhaus Bregenz, Bregenz, Austria
🇧🇪
Universitair Ziekenhuis Gent, Gent, Belgium
🇧🇪
Centre Hospitalier Regional de la Citadelle, Liege, Belgium

and more 39 locations

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Phase 3

Recruiting

Conditions: Reduction
Psoriatic Arthritis
Withdrawal

Interventions: Drug: Prednisolone
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Methotrexate
Drug: Tofacitinib
Drug: Apremilast
Drug: Etanercept
Drug: Adalimumab
Drug: Infliximab
Drug: Certolizumab pegol
Drug: Golimumab
Drug: Abatacept
Drug: Secukinumab
Drug: Ixekizumab
Drug: Ustekinumab

First Posted Date: 2020-10-30

Last Posted Date: 2022-11-14

Lead Sponsor: University of Erlangen-Nürnberg Medical School

Target Recruit Count: 270

Registration Number: NCT04610476

Locations: 🇩🇪
Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany

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