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 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
- -
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
- Conditions
- Plaque Psoriasis
- Interventions
- First Posted Date
- 2010-11-02
- Last Posted Date
- 2022-03-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 413
- Registration Number
- NCT01232283
- Locations
- 🇺🇸
Clinical Science Institute, Santa Monica, California, United States
🇺🇸Northwestern University Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
🇺🇸Radiant Research, Inc., Anderson, South Carolina, United States
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
- First Posted Date
- 2010-09-17
- Last Posted Date
- 2016-02-05
- Lead Sponsor
- Stanford University
- Registration Number
- NCT01204138
- Locations
- 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis
- Conditions
- Erosive Osteoarthritis of the Hand
- Interventions
- Drug: PlaceboDrug: Apremilast
- First Posted Date
- 2010-09-13
- Last Posted Date
- 2013-10-21
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Target Recruit Count
- 30
- Registration Number
- NCT01200472
- Locations
- 🇩🇪
Prof. Matthias Schneider, Universitätsklinikum Düsseldorf, Klinik für Endokrinologie, Diabetologie und Rheumatologie, Düsseldorf, Germany
🇩🇪Prof. G. Schett, University Hospital Erlangen, Erlangen, Bavaria, Germany
🇩🇪Prof. Ulf Müller-Ladner, Kerckhoff-Klinik, Bad Nauheim, Germany
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
- First Posted Date
- 2010-09-13
- Last Posted Date
- 2014-07-15
- Lead Sponsor
- Duke University
- Registration Number
- NCT01200264
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- First Posted Date
- 2010-09-02
- Last Posted Date
- 2022-03-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 844
- Registration Number
- NCT01194219
A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis
- First Posted Date
- 2010-06-09
- Last Posted Date
- 2015-03-04
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 5
- Registration Number
- NCT01140503
- Locations
- 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
Apremilast in the Treatment of Moderate to Severe Acne
- First Posted Date
- 2010-02-24
- Last Posted Date
- 2017-03-13
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Target Recruit Count
- 3
- Registration Number
- NCT01074502
- Locations
- 🇺🇸
University Of North Carolina, Chapel Hill, North Carolina, United States
Open Label Pilot Study of Apremilast in Treatment of Rosacea
- Conditions
- Papulopustular RosaceaErythematotelangiectatic Rosacea
- Interventions
- First Posted Date
- 2010-01-11
- Last Posted Date
- 2016-12-13
- Lead Sponsor
- Julian M. Mackay-Wiggan
- Target Recruit Count
- 10
- Registration Number
- NCT01045551
- Locations
- 🇺🇸
Columbia University Medical Center, New York, New York, United States
Apremilast Therapy for Acute Gouty Arthritis
- First Posted Date
- 2009-10-19
- Last Posted Date
- 2018-04-02
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Registration Number
- NCT00997581
- Locations
- 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Spondylitis Trial of Apremilast for Better Rheumatic Therapy
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: Placebo (sugar pill)Drug: Apremilast
- First Posted Date
- 2009-07-23
- Last Posted Date
- 2019-12-06
- Lead Sponsor
- Imperial College London
- Target Recruit Count
- 38
- Registration Number
- NCT00944658
- Locations
- 🇬🇧
The Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital, London, United Kingdom
Drug Development Updates
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