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
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Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA

Phase 2
Withdrawn
Conditions
Interventions
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

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

Phase 2
Withdrawn
Conditions
Interventions
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

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

Not Applicable
Terminated
Conditions
Interventions
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

Phase 2
Terminated
Conditions
Interventions
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

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

Phase 2
Withdrawn
Conditions
Interventions
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

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

Study of Apremilast in Atopic or Contact Dermatitis

First Posted Date
2009-07-02
Last Posted Date
2010-12-20
Lead Sponsor
Tufts Medical Center
Target Recruit Count
10
Registration Number
NCT00931242
Locations
🇺🇸

Tufts Medical Center, Department of Dermatology, Boston, Massachusetts, United States

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