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
- -
Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
- First Posted Date
- 2014-11-13
- Last Posted Date
- 2020-05-07
- Lead Sponsor
- Amgen
- Target Recruit Count
- 170
- Registration Number
- NCT02289417
- Locations
- 🇺🇸
Southern California Research Institute Medical Group, Inc., Los Angeles, California, United States
🇺🇸NYU Langone Long Island Clinical Research Associates, Great Neck, New York, United States
🇺🇸Precision Clinical Research, LLC, Lauderdale Lakes, Florida, United States
Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis
- Conditions
- Interventions
- First Posted Date
- 2014-05-22
- Last Posted Date
- 2023-05-16
- Lead Sponsor
- University of Athens
- Target Recruit Count
- 200
- Registration Number
- NCT02144857
- Locations
- 🇬🇷
Attikon Hospital, Athens, Greece
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
- First Posted Date
- 2014-03-14
- Last Posted Date
- 2020-05-07
- Lead Sponsor
- Amgen
- Target Recruit Count
- 191
- Registration Number
- NCT02087943
- Locations
- 🇺🇸
Virginia Clinical Research Inc, Norfolk, Virginia, United States
🇺🇸Mount Sinai Medical Center, New York, New York, United States
🇺🇸Renstar Medical Research, Ocala, Florida, United States
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
- Conditions
- Interventions
- First Posted Date
- 2013-11-20
- Last Posted Date
- 2020-05-07
- Lead Sponsor
- Amgen
- Target Recruit Count
- 254
- Registration Number
- NCT01988103
- Locations
- 🇯🇵
Yano Hifuka Hinyokika Clini, Fukuoka-shi, Fukuoka, Japan
🇯🇵Fukuoka University Hospital, Fukuoka-shi, Fukuoka, Japan
🇯🇵TASHIRO Dermatological Clinic, Iizuka-shi, Fukuoka, Japan
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
- Conditions
- Interventions
- First Posted Date
- 2012-09-21
- Last Posted Date
- 2022-03-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 250
- Registration Number
- NCT01690299
- Locations
- 🇺🇸
University of California Irvine-Department of Dermatology, Irvine, California, United States
🇺🇸Florida Academic Dermatology Center, Miami, Florida, United States
🇺🇸International Dermatology Research, Miami, Florida, United States
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults
- First Posted Date
- 2012-07-06
- Last Posted Date
- 2021-04-21
- Lead Sponsor
- Amgen
- Target Recruit Count
- 46
- Registration Number
- NCT01634178
- Locations
- 🇺🇸
PPD Development, Austin, Texas, United States
Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults
- First Posted Date
- 2012-07-06
- Last Posted Date
- 2021-04-14
- Lead Sponsor
- Amgen
- Target Recruit Count
- 36
- Registration Number
- NCT01634191
- Locations
- 🇺🇸
PRA International, Lenexa, Kansas, United States
🇺🇸Clinical Development Services, Dallas, Texas, United States
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
- Conditions
- Interventions
- First Posted Date
- 2012-03-23
- Last Posted Date
- 2021-06-09
- Lead Sponsor
- Amgen
- Target Recruit Count
- 21
- Registration Number
- NCT01561963
- Locations
- 🇺🇸
Quintiles, Overland Park, Kansas, United States
Apremilast for Atopic Dermatitis - A Pilot Study in Adults
- First Posted Date
- 2011-07-13
- Last Posted Date
- 2020-01-14
- Lead Sponsor
- Oregon Health and Science University
- Target Recruit Count
- 16
- Registration Number
- NCT01393158
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
- Conditions
- 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
Drug Development Updates
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