Apremilast

Generic Name: Apremilast

Brand Names: Otezla, Apremilast Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₄N_₂O_₇S

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

Associated Therapies: -

Clinical Trials

A Study of LY2775240 in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: LY2775240
Drug: Placebo
Drug: Apremilast

First Posted Date: 2016-11-15

Last Posted Date: 2017-11-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 35

Registration Number: NCT02963779

Locations: 🇸🇬
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Singapore, Singapore

Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Placebo
Drug: Apremilast

First Posted Date: 2016-06-16

Last Posted Date: 2021-07-06

Lead Sponsor: Amgen

Target Recruit Count: 28

Registration Number: NCT02802735

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Apremilast Pregnancy Exposure Registry

Active, not recruiting

Conditions: Psoriatic Arthritis
Psoriasis

Interventions: Drug: apremilast

First Posted Date: 2016-05-17

Last Posted Date: 2023-05-24

Lead Sponsor: University of California, San Diego

Target Recruit Count: 233

Registration Number: NCT02775500

Locations: 🇺🇸
University of California, San Diego, La Jolla, California, United States

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Phase 3

Recruiting

Conditions: Community-acquired Pneumonia, Influenza, COVID-19

Interventions: Other: No systemic corticosteroid
Other: No antiviral agent for COVID-19
Other: No immune modulation for COVID-19
Drug: Standard course macrolide
Other: No antiviral agent for influenza
Drug: Local standard venous thromboprophylaxis
Other: No immunoglobulin
Other: No simvastatin
Other: No cysteamine
Other: No Immune Modulator for Influenza
Other: No vitamin C
Other: No antiplatelet
Procedure: Clinician-preferred mechanical ventilation strategy
Other: No renin-angiotensin system inhibitor
Other: No endothelial modulator
Drug: Ceftriaxone
Drug: Eritoran
Drug: Moxifloxacin or Levofloxacin
Drug: Fixed-duration Hydrocortisone
Drug: Extended course macrolide
Drug: Five-days oseltamivir
Drug: Lopinavir / Ritonavir
Biological: Convalescent plasma
Drug: Angiotensin converting enzyme inhibitor
Drug: Nirmatrelvir/ritonavir
Drug: Therapeutic dose anticoagulation
Procedure: Protocolised mechanical ventilation strategy
Drug: Interferon beta-1a
Drug: Vitamin C
Drug: Simvastatin
Drug: Aspirin
Drug: Cysteamine
Drug: Imatinib
Drug: Angiotensin Receptor Blockers
Drug: Shock-dependent hydrocortisone
Drug: Ten-days oseltamivir
Drug: P2Y12 inhibitor
Drug: Conventional low dose thromboprophylaxis
Biological: Delayed administration of convalescent plasma
Drug: Piperacillin-tazobactam
Drug: Hydroxychloroquine
Drug: Anakinra
Drug: Apremilast
Drug: Baricitinib
Drug: Remdesivir
Drug: Hydroxychloroquine + lopinavir/ritonavir
Drug: Nirmatrelvir/ritonavir + remdesivir
Drug: Fixed-duration higher dose Hydrocortisone
Drug: Intermediate dose thromboprophylaxis
Drug: ARB + DMX-200
Drug: Ceftaroline
Drug: Baloxavir Marboxil
Drug: Tocilizumab
Drug: Fixed-duration dexamethasone
Drug: Amoxicillin-clavulanate
Drug: Five-days oseltamivir + baloxavir marboxil
Drug: Continuation of therapeutic dose anticoagulation
Drug: Ivermectin
Drug: Sarilumab
Drug: Ten-days oseltamivir + baloxavir marboxil

First Posted Date: 2016-04-13

Last Posted Date: 2024-07-12

Lead Sponsor: UMC Utrecht

Target Recruit Count: 20000

Registration Number: NCT02735707

Locations: 🇨🇦
Toronto Western Hospital, Toronto, Ontario, Canada
🇺🇸
University of Illinois Health, Chicago, Illinois, United States
🇦🇺
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

and more 405 locations

Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Apremilast

First Posted Date: 2016-03-01

Last Posted Date: 2019-04-02

Lead Sponsor: Florida Academic Dermatology Centers

Target Recruit Count: 20

Registration Number: NCT02695212

Locations: 🇺🇸
Florida Academic Dermatology Centers, Coral Gables, Florida, United States

Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata

Not Applicable

Completed

Conditions: Alopecia Areata

Interventions: Drug: Placebo
Drug: Apremilast

First Posted Date: 2016-02-17

Last Posted Date: 2023-11-07

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 30

Registration Number: NCT02684123

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Phase 2

Completed

Conditions: Psoriasis

Interventions: Drug: Apremilast

First Posted Date: 2015-10-15

Last Posted Date: 2020-05-07

Lead Sponsor: Amgen

Target Recruit Count: 42

Registration Number: NCT02576678

Locations: 🇩🇪
Muenster University Hospital (Universitätsklinikum Muenster), Munster, Germany
🇩🇪
Kinderkrankenhaus Wilhelmstift, Dermatologie, Hamburg, Germany
🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 15 locations

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

Phase 4

Completed

Conditions: Parapsoriasis

Interventions: Drug: Apremilast
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: Drug: apremilast

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: Apremilast
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

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