Psoriasis Clinical Trial
Official title:
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
The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
Participants who had successfully completed Study 1311.2 (NCT02054481; the lead-in study) and
met the eligibility criteria for Study M16-009 (extension study) had the option to enter the
extension study. Participants were allowed to have the End of Study Visit in the lead in
study combined with the Week 0 Visit for the extension study. At the Week 12 visit,
participants were assigned to treatment based on 90% improvement in Psoriasis Area and
Severity Index (PASI90) Score: participants with ≥PASI90 Score at Week 12 continued to
receive risankizumab 90 mg by subcutaneous (SC) injection; participants with <PASI90 Score at
Week 12 switched to risankizumab 180 mg by SC injection.
Efficacy results are summarized by the 4 treatment groups from the lead-in study, which
included the following: Participants who received risankizumab 18 mg in the lead-in study and
risankizumab in the extension study (Risankizumab 18 mg/Risankizumab); participants who
received risankizumab 90 mg in the lead-in study and risankizumab in the extension study
(Risankizumab 90 mg/Risankizumab); participants who received risankizumab 180 mg in the
lead-in study and risankizumab in the extension study (Risankizumab 180 mg/Risankizumab); and
participants who received ustekinumab (Stelara) 45 or 90 mg in the lead-in study and
risankizumab in the extension study (Ustekinumab/Risankizumab).
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