Phase 3
Completed N=108
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03875508 ↗Enrolled (actual)
108
Serious AEs
5.6%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With an Observer Rating of Successful Participant Self-administration — 100; 100 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Observer Rating of Successful Participant Self-administration |
100; 100 | — |
| PRIMARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 |
66.7 | — |
| PRIMARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 |
81.5 | — |
| PRIMARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 |
46.3 | — |
| PRIMARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16 |
84.3 | — |
| PRIMARY Percentage of Participants Who Had No Potential Hazards as Measured by an Observer |
100; 100 | — |
| PRIMARY Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) |
8.358; 8.556; 9.056; 9.817; 8.82; 9.53 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
- Participant meets following disease activity criteria:
- Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
- Candidate for systemic therapy as assessed by the investigator
Exclusion Criteria
- Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Participant has previous exposure to risankizumab
Data sourced from ClinicalTrials.gov (NCT03875508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.