Apremilast
- Generic Name
- Apremilast
- Brand Names
- Otezla, Apremilast Accord
- Drug Type
- Small Molecule
- Chemical Formula
- C22H24N2O7S
- 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 tr...
- 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
- -
A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
- First Posted Date
- 2019-04-29
- Last Posted Date
- 2022-01-20
- Lead Sponsor
- Amgen
- Target Recruit Count
- 152
- Registration Number
- NCT03930186
- Locations
- 🇯🇵
Nippon Life Hospital, Osaka, Japan
🇯🇵Mita Dermatology Clinic, Minato-ku, Japan
🇯🇵Kume Clinic, Sakai-shi, Osaka, Japan
Apremilast - Oral Lichen Planus Trial
- First Posted Date
- 2019-02-11
- Last Posted Date
- 2020-06-25
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Registration Number
- NCT03836885
- Locations
- 🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2024-06-05
- Lead Sponsor
- Amgen
- Target Recruit Count
- 119
- Registration Number
- NCT03828045
- Locations
- 🇪🇸
Universitaire Vaudoise*, Vigo, Spain
🇪🇸H Univ Canarias, Tenerife, Canarias, Spain
🇪🇸H Parc Tauli, Barcelona, Cataluña, Spain
A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis
- First Posted Date
- 2018-12-20
- Last Posted Date
- 2023-03-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 123
- Registration Number
- NCT03783026
- Locations
- 🇺🇸
The Doctors of Saint John's Medical Group, Santa Monica, California, United States
🇧🇪UZ Leuven, Leuven, Belgium
🇨🇭Hopital Universitaire Genevois - Beau-Sejour Hospital, Geneve, Switzerland
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
- First Posted Date
- 2018-12-17
- Last Posted Date
- 2024-05-14
- Lead Sponsor
- Amgen
- Target Recruit Count
- 289
- Registration Number
- NCT03777436
- Locations
- 🇺🇸
Skin Care Physicians of Georgia, Macon, Georgia, United States
🇨🇦Lynderm Research Inc, Markham, Ontario, Canada
🇺🇸Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States
A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life
- First Posted Date
- 2018-12-13
- Last Posted Date
- 2022-12-12
- Lead Sponsor
- Amgen
- Target Recruit Count
- 277
- Registration Number
- NCT03774875
- Locations
- 🇬🇧
Research Site, Stourbridge, United Kingdom
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
- First Posted Date
- 2018-11-28
- Last Posted Date
- 2021-12-03
- Lead Sponsor
- Amgen
- Target Recruit Count
- 453
- Registration Number
- NCT03757013
- Locations
- 🇫🇷
Private Practice, Torcy, Torcy, France
🇫🇷Saint-Etienne Hospital, St Priest en Jarez, France
🇫🇷Private Practice 2, Antony, Antony, France
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
- 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
The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus
- Conditions
- Interventions
- 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
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.