Deucravacitinib

Generic Name: Deucravacitinib

Brand Names: Sotyktu

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₃

CAS Number: 1609392-27-9

Unique Ingredient Identifier: N0A21N6RAU

Background: Deucravacitinib is a novel oral selective tyrosine kinase 2 (TYK2) inhibitor. Unlike other Janus kinase 1/2/3 inhibitors that bind to the conserved active domain of these non-receptor tyrosine kinases, deucravacitinib binds to the regulatory domain of TYK2 with high selectivity to this therapeutic target. This selectivity towards TYK2 may lead to an improved safety profile of deucravacitinib, as nonselective JAK inhibitors are associated with a range of adverse effects such as altered cholesterol and triglyceride levels and liver and kidney dysfunction.

Deucravacitinib was first approved by the FDA in September 2022 to treat moderate-to-severe plaque psoriasis. It was later approved by Health Canada in November 2022 and by the European Medicines Agency in March 2023.

Indication: Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is not recommended for use in combination with other potent immunosuppressants.

Associated Conditions: Severe Plaque psoriasis, Moderate Plaque psoriasis

Clinical Trials

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Recruiting

Conditions: Psoriasis

Interventions: Drug: Apremilast
Drug: Deucravacitinib

First Posted Date: 2023-02-27

Last Posted Date: 2024-07-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1500

Registration Number: NCT05744466

Locations: 🇺🇸
Local Institution, Waltham, Massachusetts, United States

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Phase 4

Recruiting

Conditions: Palmoplantar Pustulosis

Interventions: Drug: Deucravacitinib

First Posted Date: 2023-02-02

Last Posted Date: 2023-11-29

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 18

Registration Number: NCT05710185

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Phase 4

Active, not recruiting

Conditions: Psoriasis

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2023-01-27

Last Posted Date: 2025-02-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 180

Registration Number: NCT05701995

Locations: 🇺🇸
Local Institution - 0006, Phoenix, Arizona, United States
🇺🇸
Local Institution - 0034, Scottsdale, Arizona, United States
🇺🇸
Local Institution - 0015, North Little Rock, Arkansas, United States

and more 35 locations

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Phase 3

Recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2022-11-17

Last Posted Date: 2025-05-18

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 490

Registration Number: NCT05620407

Locations: 🇵🇪
Local Institution - 0100, Lima, Peru
🇺🇸
UCSD - Altman Clinical and Translational Research Institute (ACTRI), La Jolla, California, United States
🇺🇸
East Bay Rheumatology Medical Group, Inc, San Leandro, California, United States

and more 196 locations

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Phase 3

Recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Other: Placebo
Drug: Deucravacitinib

First Posted Date: 2022-11-15

Last Posted Date: 2025-05-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 490

Registration Number: NCT05617677

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Local Institution - 0229, Phoenix, Arizona, United States
🇺🇸
Local Institution - 0230, Phoenix, Arizona, United States

and more 206 locations

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Phase 2

Terminated

Conditions: Alopecia Areata

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2022-09-27

Last Posted Date: 2025-02-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 94

Registration Number: NCT05556265

Locations: 🇺🇸
Local Institution - 0013, Houston, Texas, United States
🇵🇱
Local Institution - 0025, Warsaw, Poland
🇺🇸
Local Institution - 0012, Austin, Texas, United States

and more 25 locations

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Phase 4

Completed

Conditions: Psoriasis

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2022-07-28

Last Posted Date: 2025-03-13

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 154

Registration Number: NCT05478499

Locations: 🇺🇸
Local Institution - 0001, Hot Springs, Arkansas, United States
🇺🇸
Local Institution - 0007, Indianapolis, Indiana, United States
🇺🇸
Local Institution - 0041, Louisville, Kentucky, United States

and more 26 locations

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis

Early Phase 1

Active, not recruiting

Conditions: Nail Psoriasis

Interventions: Drug: Deucravacitinib

First Posted Date: 2021-11-17

Last Posted Date: 2025-03-30

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 1

Registration Number: NCT05124080

Locations: 🇺🇸
University of Alabama at Birmingham - Department of Dermatology, Birmingham, Alabama, United States

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Deucravacitinib
Drug: Famotidine

First Posted Date: 2021-07-02

Last Posted Date: 2022-03-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 61

Registration Number: NCT04949269

Locations: 🇺🇸
Quotient Sciences Miami, Miami, Florida, United States
🇺🇸
PPD Development, LP, Austin, Texas, United States

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Phase 3

Active, not recruiting

Conditions: Psoriatic Arthritis

Interventions: Other: Placebo
Drug: Deucravacitinib

First Posted Date: 2021-06-01

Last Posted Date: 2024-05-31

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 650

Registration Number: NCT04908202

Locations: 🇨🇳
Local Institution - 0122, Tainan, Taiwan
🇨🇳
Local Institution - 0120, Taipei City, Taiwan
🇨🇳
Local Institution - 0124, Taoyuan, Taiwan

and more 178 locations

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