MedPath

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

An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Phase 2
Completed
Conditions
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Prostatitis
Interventions
First Posted Date
2008-06-19
Last Posted Date
2014-10-06
Lead Sponsor
Kenneth Peters, MD
Target Recruit Count
21
Registration Number
NCT00701311
Locations
🇺🇸

William Beaumont Hospital, Royal Oak, Michigan, United States

Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis

Phase 2
Completed
Conditions
Psoriasis
Interventions
Drug: Placebo
First Posted Date
2008-02-04
Last Posted Date
2020-04-24
Lead Sponsor
Amgen
Target Recruit Count
260
Registration Number
NCT00606450
Locations
🇨🇦

Innovaderm, Montreal, Quebec, Canada

🇨🇦

Dr Yves Poulin, Quebec City, Quebec, Canada

🇨🇿

Department of Dermatovererology, Praha, Czechia

and more 14 locations

Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis

Phase 2
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2008-01-30
Last Posted Date
2020-04-24
Lead Sponsor
Amgen
Target Recruit Count
19
Registration Number
NCT00604682
Locations
🇺🇸

University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

NYU School of Medicine, New York, New York, United States

🇺🇸

Mt Sinai School of Medicine, New York, New York, United States

Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

Phase 2
Completed
Conditions
Psoriasis-Type Psoriasis
Plaque-Type Psoriasis
Interventions
First Posted Date
2007-08-27
Last Posted Date
2020-05-07
Lead Sponsor
Amgen
Target Recruit Count
31
Registration Number
NCT00521339
Locations
🇺🇸

Oregon Medical Research Center, P.C., Portland, Oregon, United States

🇺🇸

Central Dermatology, Saint Louis, Missouri, United States

🇺🇸

Tufts-New England Medical Center Hospitals, Boston, Massachusetts, United States

and more 1 locations

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Phase 2
Completed
Conditions
Psoriatic Arthritis
Interventions
Drug: Placebo
First Posted Date
2007-04-04
Last Posted Date
2020-06-19
Lead Sponsor
Amgen
Target Recruit Count
204
Registration Number
NCT00456092
Locations
🇬🇧

Chapel Allerton Hospital, Leeds, United Kingdom

🇬🇧

Freeman Hospital, Newcastle-upon-Tyne, United Kingdom

🇨🇦

Credit Valley Rheumatology, Mississauga, Ontario, Canada

and more 34 locations
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