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
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
- 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
Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)
- First Posted Date
- 2020-08-17
- Last Posted Date
- 2020-08-17
- Lead Sponsor
- Professor Mikkel Østergaard
- Target Recruit Count
- 115
- Registration Number
- NCT04515732
- Locations
- 🇩🇰
Dansk Gigthospital, Sønderborg, Denmark
🇩🇰Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup, Glostrup, Denmark
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
- Conditions
- COVID-19
- Interventions
- Biological: dornase alfaBiological: IC14Biological: narsoplimab
- 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
Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab
- 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
- Conditions
- Recurrent Aphtous Stomatitis
- Interventions
- Drug: Placebo oral tablet
- 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
- 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
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
- 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
- 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
- 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
- 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
Drug Development Updates
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