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
-
Clinical Trials
Related News

Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)

Phase 2
Completed
Conditions
Palmoplantar Pustulosis
Interventions
Drug: Apremilast
First Posted Date
2020-10-05
Last Posted Date
2021-09-24
Lead Sponsor
Kristian Reich
Target Recruit Count
21
Registration Number
NCT04572997
Locations
🇩🇪

Universitätsmedizin Göttingen / Georg-August-Universität Department for Dermatology, Venereology and Allergology, Göttingen, Germany

🇩🇪

SCIderm GmbH, Hamburg-Harburg, Germany

🇩🇪

University Hospital Bonn, Bonn, Germany

and more 2 locations

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

Phase 3
Recruiting
Conditions
Behçet Disease
Interventions
Drug: Apremilast
Drug: Placebo
First Posted Date
2020-08-27
Last Posted Date
2024-11-18
Lead Sponsor
Amgen
Target Recruit Count
60
Registration Number
NCT04528082
Locations
🇬🇷

General Hospital of Thessaloniki Ippokrateio, Thessaloniki, Greece

🇫🇷

Hospices Civils de Lyon Hopital Femme Mere Enfant, Bron cedex, France

🇫🇷

Hopital Necker Enfants Malades, Paris, France

and more 24 locations

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

First Posted Date
2020-07-27
Last Posted Date
2024-03-19
Lead Sponsor
QuantumLeap Healthcare Collaborative
Target Recruit Count
1500
Registration Number
NCT04488081
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

🇺🇸

Sanford Health, Sioux Falls, South Dakota, United States

🇺🇸

University of Rochester Medical Center, Rochester, New York, United States

and more 33 locations

Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Apremilast
First Posted Date
2020-03-13
Last Posted Date
2024-04-19
Lead Sponsor
Tufts Medical Center
Target Recruit Count
10
Registration Number
NCT04306965
Locations
🇺🇸

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

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Phase 3
Not yet recruiting
Conditions
Recurrent Aphtous Stomatitis
Interventions
Drug: Placebo oral tablet
Drug: Apremilast
First Posted Date
2020-01-13
Last Posted Date
2021-11-22
Lead Sponsor
University Hospital, Rouen
Target Recruit Count
134
Registration Number
NCT04227314

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Phase 3
Active, not recruiting
Conditions
Psoriasis
Interventions
Drug: Apremilast
First Posted Date
2019-11-25
Last Posted Date
2024-05-16
Lead Sponsor
Amgen
Target Recruit Count
160
Registration Number
NCT04175613
Locations
🇺🇸

First OC Dermatology, Irvine, California, United States

🇨🇦

AvantDerm, Toronto, Ontario, Canada

🇪🇸

Hopsital Germans Trias I Pujol, Badalona, Spain

and more 47 locations

Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata

Phase 2
Completed
Conditions
Acne Conglobata
Interventions
Drug: Apremilast
First Posted Date
2019-11-13
Last Posted Date
2022-03-02
Lead Sponsor
Dr. Frank Behrens
Target Recruit Count
1
Registration Number
NCT04161456
Locations
🇩🇪

University Hospital Frankfurt, Frankfurt, Hessia, Germany

Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast

Phase 4
Withdrawn
Conditions
Psoriatic Arthritis
Interventions
Drug: Apremilast
First Posted Date
2019-09-25
Last Posted Date
2021-05-13
Lead Sponsor
Medical University of Graz
Registration Number
NCT04102449
Locations
🇦🇹

Medical University of Graz, Graz, Styria, Austria

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

Phase 2
Completed
Conditions
Palmoplantaris Pustulosis
Interventions
Drug: Apremilast
Drug: Placebo
First Posted Date
2019-08-15
Last Posted Date
2024-07-17
Lead Sponsor
Amgen
Target Recruit Count
90
Registration Number
NCT04057937
Locations
🇯🇵

Research Site, Tsu, Japan

A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice

Completed
Conditions
Plaque Psoriasis
First Posted Date
2019-07-24
Last Posted Date
2024-03-04
Lead Sponsor
Amgen
Target Recruit Count
184
Registration Number
NCT04031027
Locations
🇮🇹

Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico, Bari, Italy

🇮🇹

Dermatologia Ospedale Piero Palagi, Firenze, Italy

🇮🇹

UOC Dermatologia Arcispedale Sant'Anna, Cona, Italy

and more 13 locations
© Copyright 2024. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy