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
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
- First Posted Date
- 2013-08-20
- Last Posted Date
- 2020-05-12
- Lead Sponsor
- Amgen
- Target Recruit Count
- 219
- Registration Number
- NCT01925768
- Locations
- 🇦🇺
Colin Bayliss Research and Teaching Unit, Victoria Park, Western Australia, Australia
🇺🇸Bay Area Arthritis and Osteoporosis, Brandon, Florida, United States
🇨🇦Manitoba Clinic, Winnipeg, Manitoba, Canada
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
- Conditions
- PsoriasisPsoriatic Arthritis
- 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
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
- Conditions
- Ankylosing Spondyloarthritis
- Interventions
- First Posted Date
- 2012-04-24
- Last Posted Date
- 2020-05-12
- Lead Sponsor
- Amgen
- Target Recruit Count
- 490
- Registration Number
- NCT01583374
- Locations
- 🇺🇸
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
🇨🇦Credit Valley Professional Building, Mississauga, Ontario, Canada
🇨🇿PV-Medical s.r.o., Zlin, Czechia
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
- Conditions
- Healthy Subjects
- 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
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
- Conditions
- Psoriatic Arthritis
- Interventions
- First Posted Date
- 2011-03-02
- Last Posted Date
- 2022-06-14
- Lead Sponsor
- Amgen
- Target Recruit Count
- 529
- Registration Number
- NCT01307423
- Locations
- 🇺🇸
Unifour Medical Research Associatets LLC, Hickory, North Carolina, United States
🇺🇸Rockford Orthopedic Associates, LLC, Rockford, Illinois, United States
🇺🇸Atlanta Dermatology, Vein and Research Center, PC, Alpharetta, Georgia, United States
Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2011-01-28
- Last Posted Date
- 2020-05-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 237
- Registration Number
- NCT01285310
- Locations
- 🇺🇸
TriWest Research Associates, La Mesa, California, United States
🇺🇸Desert Medical Advances, Palm Desert, California, United States
🇺🇸Stanford University Medical Center, Palo Alto, California, 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
- 2010-11-02
- 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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