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

Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Phase 3

Completed

Conditions: Psoriasis

Interventions: Other: Placebo
Drug: Apremilast

First Posted Date: 2018-10-26

Last Posted Date: 2024-05-29

Lead Sponsor: Amgen

Target Recruit Count: 595

Registration Number: NCT03721172

Locations: 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Albert Einstein College of Medicine - Montefiore Medical Center, Bronx, New York, United States
🇺🇸
MedaPhase INC, Newnan, Georgia, United States

and more 61 locations

Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Apremilast (CC-10004)
Other: Placebo

First Posted Date: 2018-10-10

Last Posted Date: 2024-12-16

Lead Sponsor: Amgen

Target Recruit Count: 245

Registration Number: NCT03701763

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸
Phoenix Childrens Hospital, Phoenix, Arizona, United States

and more 96 locations

Apremilast for RAS

Phase 4

Completed

Conditions: Recurrent Aphthous Stomatitis

Interventions: Drug: Apremilast 30mg

First Posted Date: 2018-10-01

Last Posted Date: 2022-07-14

Lead Sponsor: Mayo Clinic

Target Recruit Count: 15

Registration Number: NCT03690544

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

Phase 2

Active, not recruiting

Conditions: Female Genital Disease
Lichen Planus of Vulva

Interventions: Drug: Placebo
Drug: Apremilast

First Posted Date: 2018-09-04

Last Posted Date: 2023-03-29

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 42

Registration Number: NCT03656666

Locations: 🇳🇴
Oslo University Hospital HF, Oslo, Norway

Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Other: Placebo
Drug: BMS-986165
Drug: Apremilast

First Posted Date: 2018-08-09

Last Posted Date: 2023-01-30

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 666

Registration Number: NCT03624127

Locations: 🇺🇸
Keck School of Medicine, Los Angeles, California, United States
🇯🇵
Sapporo Skin Clinic, Sapporo, Hokkaido, Japan
🇵🇱
DermoDent - Centrum Medyczne Czajkowscy, Osielsko, Poland

and more 150 locations

Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)

Completed

Conditions: Nail Psoriasis

Interventions: Drug: Apremilast

First Posted Date: 2018-08-06

Last Posted Date: 2020-07-29

Lead Sponsor: Hospital de Granollers

Target Recruit Count: 45

Registration Number: NCT03616561

Locations: 🇪🇸
Hospital General de Granollers, Granollers, Barcelona, Spain

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: BMS-986165
Other: Placebo
Drug: Apremilast

First Posted Date: 2018-08-02

Last Posted Date: 2022-12-20

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1020

Registration Number: NCT03611751

Locations: 🇺🇸
Interspond - Savin Medical Group, Miami Lakes, Florida, United States
🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 195 locations

Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)

Completed

Conditions: Arthritis, Psoriatic

Interventions: Drug: Apremilast

First Posted Date: 2018-08-01

Last Posted Date: 2024-06-05

Lead Sponsor: Amgen

Target Recruit Count: 102

Registration Number: NCT03608657

Locations: 🇨🇦
Toronto Western Hospital, University Health Network, Toronto, Canada
🇨🇦
The Waterside Clinic, Barrie, Canada
🇨🇦
Adachi Medicine Professional Corporation, Hamilton, Canada

and more 16 locations