Risankizumab: Skyrizi

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

{m} Entries

Phase
Study Indication or Disease
Study Name
M16-007 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 1 The Effect of Multiple Subcutaneous Doses of Risankizumab on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) Administered Orally in an Open-Label, One-Sequence Trial in Patients with Plaque Psoriasis with or without Concomitant Psoriatic Arthritis
M16-002 AbbVie_IU_icons_outlined_v3 Psoriatic Arthritis Phase 2 A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Dose-Ranging Study of BI 655066/ABBV-066/Risankizumab in Patients with Active Psoriatic Arthritis
M15-992 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 BI 655066 [risankizumab] Versus Placebo in a Multicenter Randomized Double-Blind Study in Patients with Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety with Randomized Withdrawal and Re-Treatment
M16-008 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparator in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis
M15-995 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 BI 655066/ABBV-066 (Risankizumab) versus Ustekinumab and Placebo Comparators in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2
M16-010 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 BI 655066/ABBV-066 (risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Incomplete Adalimumab Treatment Response (IMMvent)
M16-178 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy
M16-009 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 2 An Open Label Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab Administered Subcutaneously in Patients with Moderate to Severe Chronic Plaque Psoriasis
M16-004 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 2 A Phase II/III, Randomised, Double-Blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients with Moderate to Severe Chronic Plaque Type Psoriasis
1311.2 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 2 A 48 weeks study of three different dose regimens of BI 655066 administered subcutaneously in patients with moderate to severe chronic plaque psoriasis (randomised, dose-ranging, active-comparator-controlled (ustekinumab), double-blind within dose groups of BI 655066)
1311.1 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 1 Safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of single rising i.v. (Stage 1) and s.c. (Stage 2) doses of BI 655066 in male and female patients with moderate to severe psoriasis (randomised, double-blind, placebocontrolled within dose groups)
M16-176 AbbVie_IU_icons_outlined_v3 Psoriasis Phase 3 Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)