Skyrizi (risankizumab-rzaa) / Boehringer Ingelheim, AbbVie  >>  Phase 3
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35 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim
UltIMMa-1, NCT02684370 / 2014-005117-23: BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Checkmark ultIMMa-1; ultIMMa-2
Feb 2018 - Feb 2018: ultIMMa-1; ultIMMa-2
Checkmark Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Oct 2017 - Oct 2017: Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Completed
3
560
NA
risankizumab, ABBV-066, BI 655066, SKYRIZI, placebo for risankizumab, ustekinumab, placebo for ustekinumab
AbbVie, Boehringer Ingelheim
Psoriasis
12/16
09/17
UltIMMa-2, NCT02684357 / 2015-003622-13: BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Checkmark ultIMMa-1; ultIMMa-2
Feb 2018 - Feb 2018: ultIMMa-1; ultIMMa-2
Checkmark Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Oct 2017 - Oct 2017: Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Completed
3
577
NA
risankizumab, BI 655066, ABBV-066, SKYRIZI, ustekinumab, placebo for risankizumab, placebo for ustekinumab
AbbVie, Boehringer Ingelheim
Psoriasis
12/16
09/17
IMMvent, NCT02694523 / 2015-003623-65: BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Checkmark Results from the IMMvent in patients with psoriasis
Feb 2021 - Feb 2021: Results from the IMMvent in patients with psoriasis
Checkmark Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Oct 2017 - Oct 2017: Data from P3 trials UltIMMA-1, UltIMMA-2, IMMVent for psoriasis
Completed
3
684
NA
risankizumab, BI 655066, ABBV-066, SKYRIZI, adalimumab, Humira, ABT-D2E7, placebo for risankizumab, placebo for adalimumab
AbbVie, Boehringer Ingelheim
Psoriasis
08/17
08/17
IMMhance, NCT02672852 / 2014-005102-38: BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Checkmark Efficacy data from IMMhance study at 8th International Congress of Psoriasis from Gene to Clinic meeting in psoriasis
Dec 2017 - Dec 2017: Efficacy data from IMMhance study at 8th International Congress of Psoriasis from Gene to Clinic meeting in psoriasis
Completed
3
507
NA
Risankizumab, BI 655066, ABBV-066, SKYRIZI, Placebo
AbbVie, Boehringer Ingelheim
Psoriasis
08/17
07/18
NCT03022045: A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Completed
3
18
Japan
risankizumab, ABBV-066 BI 655066
AbbVie
Psoriasis
09/17
11/20
NCT03255382 / 2016-003718-28: A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Completed
3
120
Europe
Fumaderm, risankizumab, ABBV-066, BI 655066, SKYRIZI
AbbVie
Psoriasis
07/18
07/18
IMMPRESS, NCT03518047: Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

Completed
3
50
RoW
risankizumab, ABBV-066, BI 655066, placebo for rizankizumab
AbbVie
Psoriasis
02/20
02/20
NCT03875482: A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Completed
3
157
US
Risankizumab, ABBV-066, BI 655066, Placebo solution for risankizumab
AbbVie
Psoriasis
02/20
07/20
NCT03875508: A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Completed
3
108
US
Risankizumab, ABBV-066, BI 655066, Autoinjector
AbbVie
Psoriasis
04/20
08/20
IMMpact2, NCT03671148 / 2017-002464-40: 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)

Checkmark Efficacy and safety data from KEEPsAKE2 trial for psoriatic arthritis
Sep 2022 - Sep 2022: Efficacy and safety data from KEEPsAKE2 trial for psoriatic arthritis
Checkmark Efficacy and safety data from KEEPsAKE-1 and KEEPsAKE-2 trials for adults with active psoriatic arthritis
Sep 2021 - Sep 2021: Efficacy and safety data from KEEPsAKE-1 and KEEPsAKE-2 trials for adults with active psoriatic arthritis
Checkmark Efficacy and safety data from KEEPsAKE2 trial for psoriatic arthritis
More
Active, not recruiting
3
444
Europe, Canada, US, RoW
Placebo, Risankizumab, ABBV-066, BI 655066, SKYRIZI
AbbVie
Psoriatic Arthritis (PsA)
06/20
06/26
NCT03478787 / 2017-004932-12: Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Checkmark For moderate to severe plaque psoriasis at AAD 2020
Jun 2020 - Jun 2020: For moderate to severe plaque psoriasis at AAD 2020
Checkmark From head-to-head trial with secukinumab in moderate to severe plaque psoriasis
Jan 2020 - Jan 2020: From head-to-head trial with secukinumab in moderate to severe plaque psoriasis
Completed
3
327
Europe, Canada, US
risankizumab, ABBV-066, BI 655066, SKYRIZI, secukinumab, Cosentyx
AbbVie
Psoriasis
07/20
07/20
2020-001899-14: An unblinded clinical Trial with random assignment to Treatment Groups in adult patients with psoriatic arthrits to evaluate how far immunosuppressive medication can be tapered without recurrence of symptoms

Not yet recruiting
3
270
Europe
Prednisolone p.o., Sulfasalazine, Leflunomide, Methotrexate p.o., Methotrexate s.c., Etanercept, Adalimumab, Infliximab, Abatacept s.c., Abatacept i.v., Tablet, Coated tablet, , Solution for injection, Powder for concentrate for solution for infusion, Solution for injection in pre-filled pen, Solution for injection in pre-filled syringe, Solution for injection in dose-dispenser cartridge, Prolonged-release tablet, Xeljanz 5/10mg Filmtabletten, Otezla Filmtabletten, Simponi 50mg Injektionslösung Vorgefüllter Injektor/Fertigspritze, Cimzia 200mg Injektionslösung in einem Fertigpen, Orencia Injektionslösung in einer Fertigspritze, Orencia 250mg Pulver, Cosentyx 150mg Injektionslösung in einer Fertigspritze, Taltz, Cimzia 200mg Injektionslösung in einer Fertigspritze, Cimzia 200mg Injektionslösung in einer Patrone für ein Dosiergerät, Orencia 125mg Injektionslösung im Fertigpen, Cosentyx 150mg Injektionslösung in einem Fertigpen, Stelara 45mg/90mg Injektionslösung, Xeljanz 11mg Retardtablette, Rinvoq 15 mg Retardtablette, Tremfya 100mg Injektionslösung, Skyrizi 75/150mg Injektionslösung
Universitätsklinikum Erlangen, Universitätsklinikum Erlangen
Psoriatic arthritis Psoriasisarthritis, Psoriatic arthritis Gelenkbeteiligung bei Schuppenflechte, Diseases [C] - Immune System Diseases [C20]
 
 
KEEPsAKE 1, NCT03675308 / 2017-002465-22: A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

Checkmark Efficacy and safety data from KEEPsAKE 1 trial for psoriatic arthritis
Sep 2022 - Sep 2022: Efficacy and safety data from KEEPsAKE 1 trial for psoriatic arthritis
Checkmark Efficacy and safety data from KEEPsAKE-1 and KEEPsAKE-2 trials for adults with active psoriatic arthritis
Sep 2021 - Sep 2021: Efficacy and safety data from KEEPsAKE-1 and KEEPsAKE-2 trials for adults with active psoriatic arthritis
Checkmark Efficacy and safety data from KEEPsAKE 1 trial for psoriatic arthritis
More
Active, not recruiting
3
964
Europe, Canada, US, RoW
Placebo, Risankizumab, ABBV-066, BI 655066, SKYRIZI
AbbVie
Psoriatic Arthritis
10/20
09/26
MOTIVATE, NCT03105128 / 2016-003123-32: A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Checkmark Efficacy and safety data from ADVANCE trial for moderate to severe Crohn's disease
May 2021 - May 2021: Efficacy and safety data from ADVANCE trial for moderate to severe Crohn's disease
Checkmark Efficacy and safety data from ADVANCE trial in patients with moderately to severely active Crohn's disease
Jan 2021 - Jan 2021: Efficacy and safety data from ADVANCE trial in patients with moderately to severely active Crohn's disease
Checkmark Initiation in Crohn’s disease
More
Completed
3
931
Europe, Canada, Japan, US, RoW
placebo for risankizumab, risankizumab IV, ABBV-066 BI 655066, SKYRIZI, risankizumab SC
AbbVie
Crohn's Disease
11/20
04/21
ADVANCE, NCT03104413 / 2016-003190-17: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Checkmark Efficacy and safety data from MOTIVATE trial for moderate to severe Crohn's disease
May 2021 - May 2021: Efficacy and safety data from MOTIVATE trial for moderate to severe Crohn's disease
Checkmark Efficacy and safety data from MOTIVATE trial for moderate to severe Crohn’s disease
Jan 2021 - Jan 2021: Efficacy and safety data from MOTIVATE trial for moderate to severe Crohn’s disease
Completed
3
618
Europe, Canada, US, RoW
placebo for risankizumab IV, risankizumab SC, ABBV-066 BI 655066, SKYRIZI, risankizumab IV
AbbVie
Crohn's Disease
11/20
05/21
NCT03219437: A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Completed
3
104
RoW
risankizumab, ABBV-066, BI 655066, methotrexate
AbbVie
Psoriasis
11/21
11/21
NCT04102007 / 2019-000904-14: 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

Completed
3
244
Europe, US, RoW
Risankizumab, SKYRIZI
AbbVie, AbbVie Inc
Plaque Psoriasis
01/22
11/22
NCT04451720: Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Completed
3
119
Japan
Risankizumab, SKYRIZI, ABBV-066, Placebo
AbbVie
Palmoplantar Pustulosis (PPP)
11/22
11/22
IMMprint, NCT04713592: 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

Completed
3
174
Europe, Canada, US
Placebo for Risankizumab, Risankizumab, ABBV-066, SKYRIZI
AbbVie
Psoriasis
04/23
04/23
LIMMITLESS, NCT03047395 / 2016-003046-87: A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( )

Checkmark Long-term results of LIMMItless study in moderate to severe plaque psoriasis
Jan 2020 - Jan 2020: Long-term results of LIMMItless study in moderate to severe plaque psoriasis
Completed
3
2170
Europe, Canada, Japan, US, RoW
risankizumab, ABBV-066, Skyrizi, BI 655066
AbbVie
Psoriasis
11/23
11/23
NCT06274554: Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

Recruiting
3
120
US
Fluconazole, Diflucan, Placebo, IL-23 Therapy, Risankizumab, Ustekinumab, Guselkumab
Weill Medical College of Cornell University, The Leona M. and Harry B. Helmsley Charitable Trust
Crohn's Disease, Inflammatory Bowel Diseases
12/28
12/29
OptIMMize-1, NCT04435600 / 2019-004141-32: A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Completed
3
139
Europe, Canada, Japan, US
Risankizumab, SKYRIZI, ABBV-066, Ustekinumab
AbbVie
Psoriasis
02/24
10/24
IZAR-2, NCT06641089: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Recruiting
3
600
Europe, Canada, US, RoW
Sonelokimab, Placebo, Risankizumab
MoonLake Immunotherapeutics AG
Arthritis, Psoriatic
01/27
01/27
NCT06624228: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Active, not recruiting
3
684
Europe, Canada, Japan, US, RoW
Bimekizumab, Risankizumab, Placebo
UCB Biopharma SRL
Psoriatic Arthritis
02/26
05/26
REVAMP, NCT06880744: A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

Recruiting
3
530
Europe, Canada, US, RoW
Risankizumab, Vedolizumab
AbbVie
Ulcerative Colitis
09/28
09/28
MIGHTY, NCT07071519: A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Recruiting
3
120
Europe, US, RoW
Risankizumab, ABBV-066
AbbVie
Ulcerative Colitis
07/34
07/34
NCT07177118: Risankizumab for Fibrostenotic Crohn's Disease Treatment

Not yet recruiting
3
260
NA
Ustekinumab, Risankizumab
First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital, Second Affiliated Hospital of Wenzhou Medical University
Crohn Disease, Crohn Disease and Ulcerative Colitis
06/28
10/28
NCT06063967: A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Active, not recruiting
3
289
Europe, Canada, Japan, US, RoW
Risankizumab SC, ABBV-066, SKYRIZI, Placebo for risankizumab
AbbVie
Crohn's Disease
03/27
03/27
FORTIFY, NCT03105102 / 2016-003191-50: A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Checkmark Efficacy and safety of FORTIFY study in with crohn's disease
Oct 2022 - Oct 2022: Efficacy and safety of FORTIFY study in with crohn's disease
Checkmark Efficacy and safety data of FORTIFY in moderately to severely active Crohn's disease
May 2022 - May 2022: Efficacy and safety data of FORTIFY in moderately to severely active Crohn's disease
Checkmark Data from FORTIFY trial for Crohn's disease
More
Active, not recruiting
3
1336
Europe, Canada, Japan, US, RoW
Placebo for Risankizumab SC, Risankizumab IV, ABBV-066, BI 655066, SKYRIZI, Placebo for Risankizumab IV, Risankizumab SC, Risankizumab On-Body Injector (OBI)
AbbVie
Crohn's Disease
05/26
05/26
NCT06100744: A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Recruiting
3
40
Europe, Canada, US, RoW
Adalimumab, Risankizumab, ABBV-066, Skyrizi
AbbVie
Juvenile Psoriatic Arthritis
09/26
10/28
SEQUENCE, NCT04524611 / 2020-002674-26: 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)

Active, not recruiting
3
527
Europe, Canada, US, RoW
Risankizumab, ABBV-066, SKYRIZI, Ustekinumab
AbbVie
Crohn's Disease (CD)
02/28
02/28
M16-066, NCT03398135 / 2016-004676-22: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Jan 2024 - Dec 2024: Regulatory approval for ulcerative colitis
Jan 2023 - Dec 2023: Data readout from trial for ulcerative colitis
Checkmark Trial initiation
Jan 2018 - Jan 2018: Trial initiation
Active, not recruiting
3
1242
Europe, Canada, Japan, US, RoW
risankizumab, ABBV-066, BI 655066, SKYRIZI, placebo for risankizumab
AbbVie, AbbVie Inc
Ulcerative Colitis (UC)
09/28
02/29
RISE, NCT05995353: A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

Recruiting
3
118
Europe, Canada, Japan, US, RoW
Risankizumab, ABBV-066, SKYRIZI
AbbVie
Crohn's Disease
04/29
04/29
OptIMMize-2, NCT04862286: 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

Active, not recruiting
3
132
Europe, Canada, Japan, US
Risankizumab, ABBV-066, BI 655066, SKYRIZI, risankizumab-rzaa
AbbVie
Psoriasis
04/28
04/28
M16-067, NCT03398148 / 2016-004677-40: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Jan 2024 - Dec 2024: Regulatory approval for ulcerative colitis
Jan 2023 - Dec 2023: Data from trial for ulcerative colitis
Completed
2/3
1558
Europe, Canada, Japan, US, RoW
risankizumab IV, ABBV-066, BI 655066, placebo for risankizumab, risankizumab SC
AbbVie
Ulcerative Colitis (UC)
11/22
05/23

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