Drugs / Risankizumab
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Risankizumab

Monoclonal antibody

Developed for
psoriasis · Crohn disease · psoriatic arthritis · ulcerative colitis · atopic eczema · ankylosing spondylitis · asthma · COVID-19
+3 more · hidradenitis suppurativa · palmoplantar pustulosis · psoriasis-related juvenile idiopathic arthritis
Investigated by
AbbVie · Boehringer Ingelheim · Janssen Research & Development, LLC · Belgium Health Care Knowledge Centre · Case Western Reserve University · Chang Gung Memorial Hospital
+22 more · China Medical University Hospital · Chung Shan Medical University · Far Eastern Memorial Hospital · First Affiliated Hospital of Wenzhou Medical University · Istituto Clinico Humanitas · Jaehwan Kim · LEO Foundation · NYU Langone Health · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Oregon Medical Research Center · Radboud University Medical Center · Second Affiliated Hospital of Wenzhou Medical University · Shaare Zedek Medical Center · Taichung Veterans General Hospital · Taizhou Hospital · Universitaire Ziekenhuizen KU Leuven · University Hospital, Ghent · University Hospitals Cleveland Medical Center · University Medical Center Groningen · University of California, San Francisco · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (9) US (FDA) SKYRIZI 2021-04-26 – 2026-06-26 fda.gov
Approved EU (EMA) Skyrizi 2019-04-26 europa.eu
Approved US (FDA) SKYRIZI 2019-04-23 fda.gov

Trials 80 · started per year

today
US approved 2019
EU approved 2019
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20122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 119 trials
Phase 1 NCT07466550 Jun 2026 → Jan 2027 expected AbbVie Recruiting No outcome recorded
Phase 1 NCT07007091 Jun 2025 → Jan 2026 AbbVie Completed No outcome recorded
Phase 1 NCT06946524 May → Nov 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06937619 Apr → Nov 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06571266 Sep 2024 → Apr 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06487572 Jul 2024 → Feb 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06054425 Nov 2023 → May 2024 AbbVie Completed No outcome recorded
Phase 1 NCT05567029 Sep 2022 → Apr 2023 AbbVie Completed No outcome recorded
Phase 1 NCT05083078 Nov 2021 → Jul 2022 psoriatic arthritis Janssen Research & Development, LLC Terminated No outcome recorded
Phase 1 NCT05274087 Sep 2020 → Apr 2021 AbbVie Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07258641 Jan 2026 → Dec 2027 expected Crohn disease, ulcerative colitis University Medical Center Groningen Not yet recruiting No outcome recorded
Phase 217 trials
Phase 2 NCT07697456 Jul 2026 → Oct 2031 expected Crohn disease, ulcerative colitis AbbVie Not yet recruiting No outcome recorded
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT06865105 Apr 2025 → Dec 2027 expected psoriatic arthritis AbbVie Recruiting No outcome recorded
Phase 2 NCT06548542 Sep 2024 → Jan 2030 expected Crohn disease AbbVie Recruiting No outcome recorded
Phase 2 NCT05283135 Mar 2022 → Aug 2023 psoriasis Oregon Medical Research Center Completed No outcome recorded
Phase 2 NCT04583956 Oct 2020 → Sep 2021 COVID-19 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT03926169 Jun 2019 → Feb 2021 hidradenitis suppurativa AbbVie Completed No outcome recorded
Phase 2 NCT03706040 Dec 2018 → Oct 2020 atopic eczema AbbVie Completed No outcome recorded
Phase 2 NCT02986373 Dec 2016 → Jul 2018 psoriatic arthritis AbbVie Completed No outcome recorded
Phase 2 NCT03000075 Dec 2016 → Sep 2017 psoriasis AbbVie Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03398148 Mar 2018 → Nov 2022 ulcerative colitis AbbVie Completed No outcome recorded
Phase 330 trials
Phase 3 NCT07499232 Apr 2026 → Nov 2028 expected Crohn disease Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT07177118 Oct 2025 → Jun 2028 expected Crohn disease First Affiliated Hospital of Wenzhou Medical University Not yet recruiting No outcome recorded
Phase 3 NCT07071519 Jul 2025 → Jul 2034 expected ulcerative colitis AbbVie Recruiting No outcome recorded
Phase 3 NCT06100744 Jul 2024 → Sep 2026 expected psoriasis-related juvenile idiopathic arthritis AbbVie Recruiting No outcome recorded
Phase 3 NCT05995353 Dec 2023 → Apr 2029 expected Crohn disease AbbVie Recruiting No outcome recorded
Phase 3 NCT06063967 Nov 2023 → Mar 2027 expected Crohn disease AbbVie Active not recruiting No outcome recorded
Phase 3 NCT04862286 Jul 2021 → Apr 2028 expected psoriasis AbbVie Active not recruiting No outcome recorded
Phase 3 NCT04713592 Feb 2021 → Apr 2023 psoriasis AbbVie Completed No outcome recorded
Phase 3 NCT04524611 Sep 2020 → Feb 2028 expected Crohn disease AbbVie Active not recruiting No outcome recorded
Phase 3 NCT04451720 Jul 2020 → Nov 2022 palmoplantar pustulosis AbbVie Completed No outcome recorded
Phase 411 trials
Phase 4 NCT07352566 Aug 2026 → Jun 2030 expected atopic eczema, psoriasis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT07149792 Jul 2025 → Dec 2026 expected psoriasis, psoriatic arthritis Taichung Veterans General Hospital Recruiting No outcome recorded
Phase 4 NCT06333860 May 2024 → Mar 2026 psoriasis AbbVie Completed No outcome recorded
Phase 4 NCT06346288 Apr 2024 → Feb 2026 inflammatory bowel disease AbbVie Completed No outcome recorded
Phase 4 NCT05969223 Aug 2023 → Jan 2025 psoriasis AbbVie Completed No outcome recorded
Phase 4 NCT05270733 Nov 2022 → Dec 2026 expected psoriasis University Hospitals Cleveland Medical Center Recruiting No outcome recorded
Phase 4 NCT05169593 Sep 2022 → Oct 2027 expected Crohn disease Universitaire Ziekenhuizen KU Leuven Recruiting No outcome recorded
Phase 4 NCT04908475 Jun 2021 → Apr 2023 psoriasis AbbVie Completed No outcome recorded
Phase 4 NCT04630652 Apr 2021 → May 2025 psoriasis Jaehwan Kim Completed No outcome recorded
Phase 4 NCT04722640 Jan 2021 → Jan 2022 psoriasis Istituto Clinico Humanitas Unknown No outcome recorded
Phase not applicable1 trial
NCT06298188 Oct 2024 → Oct 2026 expected Crohn disease Shaare Zedek Medical Center Recruiting No outcome recorded
Also used as a comparator or background therapy in 8 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07258745 Comparator Nov 2025 → Sep 2026 expected psoriasis Chong Kun Dang Pharmaceutical Recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT06880744 Comparator Jun 2025 → Aug 2027 expected ulcerative colitis AbbVie Active not recruiting No outcome recorded
Phase 3 NCT06624228 Comparator Oct 2024 → Feb 2026 psoriatic arthritis UCB Biopharma SRL Completed No outcome recorded
Phase 3 NCT06641089 Comparator Oct 2024 → Jan 2027 expected psoriatic arthritis MoonLake Immunotherapeutics AG Recruiting No outcome recorded
Phase 3 NCT06274554 Background Oct 2024 → Dec 2028 expected Crohn disease Weill Medical College of Cornell University Recruiting No outcome recorded
Phase 3 NCT04505410 Comparator Sep 2020 → Dec 2023 ulcerative colitis University of Miami Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05928039 Comparator Oct 2023 → Jul 2027 expected Crohn disease University of Calgary Recruiting No outcome recorded
Phase not stated1 trial
NCT03914261 Background Crohn disease, ulcerative colitis AbbVie No longer available No outcome recorded

Press releases naming this drug 49 releases

DateIssuerRelease
2026-06-26 AbbVie SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease abbvie.com
2026-06-23 AbbVie AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis abbvie.com
2026-04-27 AbbVie AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease abbvie.com
2026-03-02 AbbVie AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease abbvie.com
2024-07-26 AbbVie AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com
2024-06-18 AbbVie U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease abbvie.com
2024-05-31 AbbVie AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com
2023-10-15 AbbVie AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints abbvie.com
2023-09-12 AbbVie AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease abbvie.com
2023-08-28 AbbVie AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis abbvie.com
2023-07-26 AbbVie SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study abbvie.com
2023-06-15 AbbVie Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients abbvie.com

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 95 sources stand behind the page.

FieldValueCited text
Known as risankizumab “Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by...” NCT05270733
83

risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling” PMID 28423301 Apr 2017

Risankizumab: Induction with 600 mg IV at day 0, week 4 and week 8; maintenance with 360 mg SC at week 12 and every eight weeks thereafter.” NCT05169593

“new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410

“IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554

“S. pyogenes + risankizumab (2 μg/mL)” NCT07149792

NCT03104413

NCT03671148

NCT05567029

NCT04524611

NCT02672852

NCT06298188

NCT06946524

NCT04435600

NCT03675308

NCT02031276

NCT03022045

NCT06100744

NCT06641089

NCT02986373

NCT06571266

NCT04254783

NCT04630652

NCT04908475

NCT04340076

NCT02694523

NCT03875482

NCT03255382

NCT03875508

NCT06333860

NCT05083078

NCT07007091

NCT06880744

NCT03926169

NCT02772601

NCT07697456

NCT03478787

NCT06346288

NCT04451720

NCT05274100

NCT04583956

NCT06624228

NCT06865105

NCT04102007

NCT05928039

NCT05969223

NCT02513459

NCT06054425

NCT06487572

NCT02443298

NCT06063967

NCT03914261

NCT05274087

NCT02684370

NCT03398148

NCT03219437

NCT07177118

NCT03398135

NCT04713592

NCT03706040

NCT06937619

NCT03047395

NCT02047110

NCT02203851

NCT02684357

NCT07352566

NCT07499232

NCT07071519

NCT07138898

NCT03518047

NCT05268068

NCT03000075

NCT07466550

NCT02719171

NCT05305222

NCT03105128

NCT05283694

NCT03105102

NCT04862286

NCT05283681

NCT05995353

NCT05283135

NCT06548542

NCT07258641

Known as ABBV-066 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02596217
Known as BI 655066 “risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling” PMID 28423301 Apr 2017
1

NCT01577550

Known as RISA “Patients were classified into five cohorts on the basis of their treatment experience during the follow-up period: risankizumab (RISA) only, RISA followed by re-randomization...” PMID 34921669 Dec 2021
Known as Risakizumab “Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40.” NCT04722640
Known as risankizumab-800CW “fluorescently labeled adalimumab (adalimumab-680LT) and risankizumab (risankizumab-800CW)” NCT07258641
Known as risankizumab-rzaa “In this study, subjects with moderate-to-severe psoriasis will receive FDA-approved anti-IL-23p19 antibody (Generic name: Risankizumab, Product name: SKYRIZI™ or...” NCT04630652
Known as RZB “OBJECTIVES: Determine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and...” PMID 35701011 Jun 2022
3

“This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis in the phase 3...” PMID 40168091 Apr 2025

“Risankizumab (RZB) and deucravacitinib (DEU) are both approved for the treatment of moderate-to-severe psoriasis.” PMID 42143644 May 2026

“To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis.” PMID 34157132 Sep 2021

Known as Skyrizi “EU-approved Skyrizi®, and US-licensed Skyrizi®” NCT07258745
2

NCT07258745

NCT04722640

Action Inhibit “Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis” PMID 29945918 Jun 2018
Modality Monoclonal antibody “anti-interleukin (IL)-23 monoclonal antibodyPMID 31054118 Oct 2019
Route Intravenous “risankizumab administered by IV infusion” NCT02031276