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

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Phase 4

Completed

Conditions: Psoriasis

Interventions: Drug: Risankizumab
Drug: Apremilast

First Posted Date: 2021-06-01

Last Posted Date: 2024-04-30

Lead Sponsor: AbbVie

Target Recruit Count: 352

Registration Number: NCT04908475

Locations: 🇺🇸
Epiphany Dermatology of Kansas LLC /ID# 229221, Overland Park, Kansas, United States
🇺🇸
Center for Clinical Studies - Houston (Binz) /ID# 229272, Houston, Texas, United States
🇺🇸
UC Davis Health /ID# 229133, Sacramento, California, United States

and more 51 locations

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Phase 3

Conditions: Psoriasis

Interventions: Drug: Risankizumab

First Posted Date: 2021-04-27

Last Posted Date: 2024-06-17

Lead Sponsor: AbbVie

Target Recruit Count: 132

Registration Number: NCT04862286

Locations: 🇩🇪
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883, Kiel, Schleswig-Holstein, Germany
🇺🇸
First OC Dermatology /ID# 226942, Fountain Valley, California, United States
🇺🇸
Solutions Through Adv Rch /ID# 226104, Jacksonville, Florida, United States

and more 36 locations

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

Recruiting

Conditions: Other Conditions for Which Risankizumab is an FDA-approved Treatment
Plaque Psoriasis
Crohn Disease
Psoriatic Arthritis

Interventions: Drug: Risankizumab
Drug: Comparator

First Posted Date: 2021-04-15

Last Posted Date: 2024-03-06

Lead Sponsor: AbbVie

Target Recruit Count: 818

Registration Number: NCT04846959

Locations: 🇺🇸
Evidera, a PPD Business Unit /ID# 238688, Morrisville, North Carolina, United States
🇺🇸
PPD Development, LP /ID# 232134, Wilmington, North Carolina, United States

Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

Withdrawn

Conditions: Psoriasis

Interventions: Drug: Comparator 2
Biological: Comparator 1
Drug: Risankizumab

First Posted Date: 2021-03-16

Last Posted Date: 2022-12-09

Lead Sponsor: AbbVie

Registration Number: NCT04799990

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Placebo for Risankizumab
Drug: Risankizumab

First Posted Date: 2021-01-19

Last Posted Date: 2024-06-14

Lead Sponsor: AbbVie

Target Recruit Count: 174

Registration Number: NCT04713592

Locations: 🇺🇸
Menter Dermatology Res Inst /ID# 219161, Dallas, Texas, United States
🇺🇸
Medderm Associates /ID# 219210, San Diego, California, United States
🇺🇸
Dawes Fretzin, LLC /ID# 219219, Indianapolis, Indiana, United States

and more 52 locations

Risankizumab Long-term Remission Study

Phase 4

Active, not recruiting

Conditions: Psoriasis

Interventions: Drug: Risankizumab-Rzaa
Procedure: Punch biopsies of the skin at baseline visit
Procedure: Punch biopsies of the skin at week 28 visit

First Posted Date: 2020-11-16

Last Posted Date: 2024-10-04

Lead Sponsor: Jaehwan Kim

Target Recruit Count: 20

Registration Number: NCT04630652

Locations: 🇺🇸
VA Northern California Health Care System, Sacramento, California, United States
🇺🇸
University of California Davis Medical Center, Sacramento, California, United States
🇺🇸
The Rockefeller Univesity, New York, New York, United States

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Phase 3

Active, not recruiting

Conditions: Crohn's Disease (CD)

Interventions: Drug: Ustekinumab
Drug: Risankizumab

First Posted Date: 2020-08-24

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 527

Registration Number: NCT04524611

Locations: 🇪🇸
Hospital Universitario Virgen Macarena /ID# 223315, Sevilla, Spain
🇪🇸
Hospital Clinico Universitario de Valencia /ID# 223321, Valencia, Spain
🇨🇦
Axler, Toronto, ON. Canada /ID# 223740, Toronto, Ontario, Canada

and more 297 locations

Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Phase 3

Completed

Conditions: Palmoplantar Pustulosis (PPP)

Interventions: Drug: Risankizumab
Drug: Placebo

First Posted Date: 2020-06-30

Last Posted Date: 2022-12-05

Lead Sponsor: AbbVie

Target Recruit Count: 119

Registration Number: NCT04451720

Locations: 🇯🇵
St.Luke's International Hospital /ID# 219019, Chuo-ku, Tokyo, Japan
🇯🇵
Tokyo Medical University Hospital /ID# 218893, Shinjuku-ku, Tokyo, Japan
🇯🇵
Seibo Hospital /ID# 221691, Shinjuku-ku, Tokyo, Japan

and more 36 locations

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: Risankizumab
Drug: Ustekinumab

First Posted Date: 2020-06-17

Last Posted Date: 2024-10-26

Lead Sponsor: AbbVie

Target Recruit Count: 150

Registration Number: NCT04435600

Locations: 🇩🇪
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881, Dresden, Sachsen, Germany
🇯🇵
Duplicate_Teikyo University Hospital /ID# 255188, Itabashi-ku, Tokyo, Japan
🇬🇧
Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078, Exeter, Devon, United Kingdom

and more 50 locations

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Phase 4

Active, not recruiting

Conditions: Psoriasis
Psoriasis Vulgaris

Interventions: Drug: Secukinumab
Drug: Ixekizumab
Drug: Brodalumab
Drug: Guselkumab
Drug: Risankizumab
Drug: Tildrakizumab
Drug: Bimekizumab

First Posted Date: 2020-04-09

Last Posted Date: 2024-01-19

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 244

Registration Number: NCT04340076

Locations: 🇳🇱
Amphia Hospital, Breda, Netherlands
🇳🇱
Radboudumc, Nijmegen, Netherlands
🇳🇱
Máxima Medisch Centrum, Veldhoven, Netherlands

and more 16 locations

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