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
-

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-11-27
Lead Sponsor
Alumis Inc
Target Recruit Count
840
Registration Number
NCT06586112
Locations
🇺🇸

Exalt Clinical Research, Chula Vista, California, United States

🇺🇸

California Dermatology & Clinical Research Institute, Encinitas, California, United States

🇺🇸

Marvel Clinical Research, LLC, Huntington Beach, California, United States

and more 48 locations

A Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-12-20
Lead Sponsor
Alumis Inc
Target Recruit Count
840
Registration Number
NCT06588738
Locations
🇨🇦

CCA Medical Research Corp, Ajax, Ontario, Canada

🇨🇦

SKiN Health, Cobourg, Ontario, Canada

🇨🇦

Kingsway Clinical Research, Etobicoke, Ontario, Canada

and more 42 locations

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

First Posted Date
2024-04-25
Last Posted Date
2024-04-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
600
Registration Number
NCT06382987
Locations
🇯🇵

Mebix. Inc., Minato-ku, Tokyo, Japan

🇯🇵

Fukuoka University Hospital, Fukuoka, Japan

Apremilast for Alcohol Use Disorder Treatment in Women and Men

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2024-03-22
Last Posted Date
2024-08-13
Lead Sponsor
Yale University
Target Recruit Count
10
Registration Number
NCT06324435
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus

Phase 4
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-02-15
Last Posted Date
2024-02-15
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
64
Registration Number
NCT06260904
Locations
🇮🇳

AIIMS Bhubaneswar, Bhubaneswar, Odisha, India

A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2023-11-08
Last Posted Date
2024-11-25
Lead Sponsor
Amgen
Target Recruit Count
203
Registration Number
NCT06122649
Locations
🇨🇳

Peking University First Hospital, Beijing, Beijing, China

🇨🇳

The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

🇨🇳

The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

and more 18 locations

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2023-10-31
Last Posted Date
2024-10-16
Lead Sponsor
Takeda
Target Recruit Count
1108
Registration Number
NCT06108544
Locations
🇺🇸

Advanced Medical Research, PC, Atlanta, Georgia, United States

🇨🇦

Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS, Saskatoon, Saskatchewan, Canada

🇵🇱

ETG Siedlce - PPDS, Siedlce, Mazowieckie, Poland

and more 214 locations

A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2023-10-18
Last Posted Date
2024-12-13
Lead Sponsor
Amgen
Target Recruit Count
50
Registration Number
NCT06088199
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Affiliated Dermatology, Scottsdale, Arizona, United States

🇺🇸

Clear Dermatology, Scottsdale, Arizona, United States

and more 27 locations

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2023-10-18
Last Posted Date
2024-10-16
Lead Sponsor
Takeda
Target Recruit Count
693
Registration Number
NCT06088043
Locations
🇺🇸

Saguaro Dermatology Associates, LLC - Probity - PPDS, Phoenix, Arizona, United States

🇺🇸

First OC Dermatology - Fountain Valley, Fountain Valley, California, United States

🇺🇸

Center for Dermatology Clinical Research, Fremont, California, United States

and more 129 locations

Apremilast for Erythema Multiforme

Phase 2
Recruiting
Conditions
First Posted Date
2023-05-25
Last Posted Date
2024-07-31
Lead Sponsor
Robert Micheletti
Target Recruit Count
8
Registration Number
NCT05875714
Locations
🇺🇸

Perelman Center For Advanced Medicine, Philadelphia, Pennsylvania, United States

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