Phase 3
Completed N=12
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Source: ClinicalTrials.gov NCT01952015 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) — 10; 2; 9; 1 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 This can indicate results are unpublished — a known publication-bias signal.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 purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) |
10; 2; 9; 1; 0; 1 | — |
| SECONDARY Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) |
10; 2; 7; 2; 1; 0 | — |
| SECONDARY Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) |
8; 1; 0; 0; 0; 0 | — |
| SECONDARY Summary of Clinical Global Impression up to End of Trial |
4; 5; 1; 1; 0; 0 | — |
| SECONDARY Summary of JDA Total Score Category for GPP by Visit up to End of Trial |
0; 9; 3; 0; 0; 0 | — |
| SECONDARY The Japanese Dermatological Association (JDA) Component Score for GPP Over Time |
2; 0.3; 0.0; 0.0; 1.6; 1.1 | — |
| SECONDARY Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP |
-89.09; -100.00; -100.00; -63.56; -83.60; -87.01 | — |
| SECONDARY Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time |
8.4; 4.5; 2.7; 4.7; 43.69; 46.70 | — |
| SECONDARY Number of Patients With GPP-related Systemic and Topical Co-medication Over Time |
12; 8 | — |
Eligibility Criteria
Inclusion Criteria
- At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
- At baseline, erythema area with pustule ≥ 10%
Exclusion Criteria
- Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
- At baseline, : total score of JDA severity index for GPP ≥ 14
- Drug-induced psoriasis
- Ongoing use of prohibited psoriasis treatments.
Data sourced from ClinicalTrials.gov (NCT01952015). 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.