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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
Clinical Trials
Related News

Treatment With Apremilast in Patients With Psoriatic Arthritis

Phase 4
Withdrawn
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2015-09-24
Last Posted Date
2016-10-21
Lead Sponsor
University of South Florida
Registration Number
NCT02558361
Locations
🇺🇸

Morsani Center for Advanced healthcare, Tampa, Florida, United States

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Phase 4
Completed
Conditions
Parapsoriasis
Interventions
Drug: Placebo
Drug: Placebo-Apremilast
First Posted Date
2015-04-24
Last Posted Date
2023-06-05
Lead Sponsor
Amgen
Target Recruit Count
221
Registration Number
NCT02425826
Locations
🇺🇸

Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, United States

🇺🇸

UConn Health Center, Farmington, Connecticut, United States

🇺🇸

Dermatology Research Associates, Los Angeles, California, United States

and more 23 locations

Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis

Phase 4
Completed
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2015-04-09
Last Posted Date
2019-01-28
Lead Sponsor
Psoriasis Treatment Center of Central New Jersey
Target Recruit Count
29
Registration Number
NCT02412644
Locations
🇺🇸

Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, United States

Apremilast in Palmo-Plantar Psoriasis

Phase 4
Completed
Conditions
Palmo-plantar Psoriasis
Interventions
Drug: Placebo
First Posted Date
2015-03-27
Last Posted Date
2018-11-20
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
100
Registration Number
NCT02400749
Locations
🇨🇦

Innovaderm Investigational Site, Québec, Canada

A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease

Phase 3
Completed
Conditions
Behçet's Syndrome
Interventions
Drug: Placebo
First Posted Date
2014-12-04
Last Posted Date
2021-07-22
Lead Sponsor
Amgen
Target Recruit Count
207
Registration Number
NCT02307513
Locations
🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

University of Pennsylvania Health Systems, Philadelphia, Pennsylvania, United States

🇮🇱

Bnai Zion Medical Center, Haifa, Israel

and more 60 locations

Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: Placebo
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

and more 96 locations

Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

First Posted Date
2014-09-11
Last Posted Date
2021-06-01
Lead Sponsor
Amgen
Target Recruit Count
80
Registration Number
NCT02236988
Locations
🇺🇸

Covance Clinical Research Unit Inc., Madison, Wisconsin, United States

Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

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

Phase 2
Completed
Conditions
Dermatitis, Atopic Dermatitis
Interventions
Drug: Placebo
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

and more 28 locations

Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

Phase 2
Completed
Conditions
Psoriatic Arthritis
Psoriasis Arthropatica
Psoriasis
Interventions
Drug: Placebo
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

and more 52 locations
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