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

Clinical Trials

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: 2025-02-06

Lead Sponsor: Amgen

Target Recruit Count: 33

Registration Number: NCT05565560

Locations: 🇯🇵
Nagoya City University Hospital, Nagoya-shi, Aichi, Japan
🇯🇵
Fukuoka University Hospital, Fukuoka-shi, Fukuoka, Japan
🇯🇵
Hospital of the University of Occupational and Environmental Health Japan, Kitakyushu-shi, Fukuoka, Japan

and more 26 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: 2025-04-09

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: 2025-04-13

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 729

Registration Number: NCT04908189

Locations: 🇨🇳
Local Institution - 0140, Pingxiang, Jiangxi, China
🇨🇳
Local Institution - 0191, Shenyang, Liaoning, China
🇨🇳
Local Institution - 0158, Baotou, Neimeng, China

and more 144 locations

A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: EU-sourced Otezla®
Drug: US-sourced Otezla®
Drug: Japan-sourced Otezla®

First Posted Date: 2021-03-23

Last Posted Date: 2023-08-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 20

Registration Number: NCT04811573

Locations: 🇩🇪
Humanpharmakologisches Zentrum Biberach, Biberach, Germany

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: 2025-02-26

Lead Sponsor: Amgen

Target Recruit Count: 60

Registration Number: NCT04804553

Locations: 🇬🇧
Nottingham Childrens Hospital, Nottingham, United Kingdom
🇮🇹
Ospedale Santissima Annunziata, Chieti, Italy
🇦🇹
Landeskrankenhaus Bregenz, Bregenz, Austria

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

Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: Standard of care
Drug: Zilucoplan placebo
Drug: Apremilast placebo
Drug: Lanadelumab placebo
Drug: Lanadelumab
Drug: Apremilast
Drug: Zilucoplan

First Posted Date: 2020-10-19

Last Posted Date: 2022-06-29

Lead Sponsor: Amgen

Target Recruit Count: 515

Registration Number: NCT04590586

Locations: 🇺🇸
The University of Iowa, Iowa City, Iowa, United States
🇺🇸
Sharp Chula Vista Medical Center, Chula Vista, California, United States
🇷🇺
SPb SBIH "Alexandrovskaya City Hospital", Saint Petersburg, Russian Federation

and more 56 locations

Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)

Phase 2

Completed

Conditions: Palmoplantar Pustulosis

Interventions: Drug: Apremilast

First Posted Date: 2020-10-05

Last Posted Date: 2021-09-24

Lead Sponsor: Kristian Reich

Target Recruit Count: 21

Registration Number: NCT04572997

Locations: 🇩🇪
Universitätsmedizin Göttingen / Georg-August-Universität Department for Dermatology, Venereology and Allergology, Göttingen, Germany
🇩🇪
SCIderm GmbH, Hamburg-Harburg, Germany
🇩🇪
University Hospital Bonn, Bonn, Germany

and more 2 locations

The Maintenance Effect of Enstilar Foam in Combination With Otezla

Phase 4

Conditions: Psoriasis

Interventions: Drug: Apremilast 30mg
Drug: calcipotriene and betamethasone dipropionate

First Posted Date: 2020-09-21

Last Posted Date: 2020-10-09

Lead Sponsor: Derm Research, PLLC

Target Recruit Count: 30

Registration Number: NCT04555707

Locations: 🇺🇸
Skin Sciences, PLLC, Louisville, Kentucky, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy