Risankizumab

Generic Name: Risankizumab

Brand Names: Skyrizi 150 Mg Dose Pack, Skyrizi

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1612838-76-2

Unique Ingredient Identifier: 90ZX3Q3FR7

Background: Risankizumab is a fully humanized IgG1 monoclonal antibody (mAb) directed against interleukin 23 (IL-23). It gained its first global approval in Japan in March 2019, followed by approval in Canada, the US, and Europe in April 2019. Risankizumab is used to treat plaque psoriasis, psoriatic arthritis, and Crohn's disease. Risankizumab is being investigated for...

Indication: Risankizumab is indicated to treat:

Associated Conditions: Moderate plaque-type psoriasis, Psoriasis, Psoriatic Arthritis, Severe Plaque Type Psoriasis, Active Psoriatic arthritis, Moderate, active Crohn´s Disease, Moderate, severe Psoriasis Vulgaris (Plaque Psoriasis), Severe, active Crohn´s Disease

Associated Therapies: -

Clinical Trials

A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Phase 1

Completed

Conditions: Ulcerative Colitis (UC)
Crohn's Disease

Interventions: Drug: Risankizumab
Drug: Cytochrome P450 (CYP) Substrates

First Posted Date: 2020-02-05

Last Posted Date: 2024-07-01

Lead Sponsor: AbbVie

Target Recruit Count: 20

Registration Number: NCT04254783

Locations: 🇺🇸
University Clinical Research /ID# 216823, DeLand, Florida, United States
🇺🇸
Southern California Res. Ctr. /ID# 216257, Coronado, California, United States
🇺🇸
Clinical Trials of Texas, Inc /ID# 216277, San Antonio, Texas, United States

and more 3 locations

A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Risankizumab

First Posted Date: 2019-09-25

Last Posted Date: 2023-11-27

Lead Sponsor: AbbVie

Target Recruit Count: 244

Registration Number: NCT04102007

Locations: 🇬🇧
Northern Care Alliance NHS Group /ID# 213873, Salford, United Kingdom
🇺🇸
Burke Pharmaceutical Research /ID# 225023, Hot Springs, Arkansas, United States
🇺🇸
Arkansas Research Trials /ID# 225497, North Little Rock, Arkansas, United States

and more 54 locations

A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Risankizumab
Drug: Placebo for risankizumab

First Posted Date: 2019-04-24

Last Posted Date: 2022-08-11

Lead Sponsor: AbbVie

Target Recruit Count: 243

Registration Number: NCT03926169

Locations: 🇫🇷
HCL - Hopital Edouard Herriot /ID# 218408, Lyon, France
🇺🇸
Minnesota Clinical Study Center /ID# 211979, New Brighton, Minnesota, United States
🇺🇸
Burke Pharmaceutical Research /ID# 211671, Hot Springs, Arkansas, United States

and more 56 locations

Expanded Access to Risankizumab

Conditions: Crohn's Disease
Ulcerative Colitis (UC)

First Posted Date: 2019-04-16

Last Posted Date: 2022-05-24

Lead Sponsor: AbbVie

Registration Number: NCT03914261

A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Placebo solution for risankizumab
Drug: Risankizumab

First Posted Date: 2019-03-14

Last Posted Date: 2021-03-16

Lead Sponsor: AbbVie

Target Recruit Count: 157

Registration Number: NCT03875482

Locations: 🇺🇸
Anaheim Clinical Trials LLC /ID# 212559, Anaheim, California, United States
🇺🇸
Skin Laser and Surgery Specialists of NY and NJ /ID# 210208, Hackensack, New Jersey, United States
🇺🇸
Arlington Research Center, Inc /ID# 210344, Arlington, Texas, United States

and more 40 locations

A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Risankizumab
Device: Autoinjector

First Posted Date: 2019-03-14

Last Posted Date: 2021-05-11

Lead Sponsor: AbbVie

Target Recruit Count: 108

Registration Number: NCT03875508

Locations: 🇺🇸
Tien Q Nguyen MD, Inc /ID# 210775, Fountain Valley, California, United States
🇺🇸
Advanced Research Associates /ID# 210634, Glendale, Arizona, United States
🇺🇸
Bakersfield Derma & Skin Cance /ID# 210773, Bakersfield, California, United States

and more 23 locations

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

Phase 3

Active, not recruiting

Conditions: Psoriatic Arthritis (PsA)

Interventions: Biological: Placebo
Biological: Risankizumab

First Posted Date: 2018-09-14

Last Posted Date: 2024-11-13

Lead Sponsor: AbbVie

Target Recruit Count: 444

Registration Number: NCT03671148

Locations: 🇺🇸
Arthritis and Rheumatology /ID# 169438, Atlanta, Georgia, United States
🇺🇸
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681, Skokie, Illinois, United States
🇺🇸
DM Clinical Research /ID# 208350, Tomball, Texas, United States

and more 135 locations

Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: risankizumab
Drug: placebo for rizankizumab

First Posted Date: 2018-05-08

Last Posted Date: 2021-01-25

Lead Sponsor: AbbVie

Target Recruit Count: 50

Registration Number: NCT03518047

Locations: 🇷🇺
GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713, Krasnodar, Krasnodarskiy Kray, Russian Federation
🇷🇺
LLC Kurator /ID# 200616, Saint-Petersburg, Sankt-Peterburg, Russian Federation
🇷🇺
Alliance Biomedical Ural Group /ID# 201681, Izhevsk, Udmurtskaya Respublika, Russian Federation

and more 3 locations

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: risankizumab
Drug: secukinumab

First Posted Date: 2018-03-27

Last Posted Date: 2021-07-13

Lead Sponsor: AbbVie

Target Recruit Count: 327

Registration Number: NCT03478787

Locations: 🇨🇦
Beacon Dermatology Inc /ID# 203054, Calgary, Alberta, Canada
🇫🇷
Hopital Saint-Louis /ID# 203586, Paris, France
🇺🇸
Progressive Medical Research /ID# 202183, Port Orange, Florida, United States

and more 58 locations

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Phase 3

Active, not recruiting

Conditions: Ulcerative Colitis (UC)

Interventions: Drug: placebo for risankizumab
Drug: risankizumab

First Posted Date: 2018-01-12

Last Posted Date: 2024-10-08

Lead Sponsor: AbbVie

Target Recruit Count: 1242

Registration Number: NCT03398135

Locations: 🇺🇸
Cedars-Sinai Medical Center /ID# 163848, Los Angeles, California, United States
🇺🇸
UCSF Medical Center - Mount Zion /ID# 201209, San Francisco, California, United States
🇺🇸
Duplicate_Medical Research Center of CT /ID# 160287, Hamden, Connecticut, United States

and more 422 locations

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