Phase 3
Completed N=182
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01636687 ↗
Enrolled (actual)
182
Serious AEs
9.5%
Results posted
Sep 2018
Primary outcomePrimary: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response — 71.7; 86.7; 3.3; 53.3 Percentages of participants — p=<0.0001
◆ Published Evidence
Established
38citations · ~10 / year
Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
Summary
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Linked Publications (5)
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Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
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Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies.
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Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab.
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Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies.
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Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response |
71.7; 86.7; 3.3; 53.3; 73.3; 0.0 | <0.0001 sig |
| SECONDARY Percentages of Subjects With Successful Self-administration of Study Drug at Week 1 |
100; 100; 100 | — |
| SECONDARY Percentage of Subjects With Possible Use-related Hazards |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 |
0.94; 1.13; 0.93; 1.76; 1.68; 1.00 | — |
| SECONDARY Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 |
0.92; 1.34; 1.43; 0.73; 0.42; 1.88 | — |
| SECONDARY Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period |
78.3; 96.7; 8.2; 40.0; 55.0; 0.0 | — |
| SECONDARY Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data) |
64.7; 70.7; 56.0; 85.7; 82.4; 82.8 | — |
| SECONDARY Absolute Change From Baseline for PASI Score - Induction Period |
-15.52; -16.67; -1.26 | — |
| SECONDARY Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data) |
-18.3; -16.4; -15.2; -18.8 | — |
| SECONDARY Percentage of Participants in Each IGA Mod 2011 Category - Induction Period |
18.3; 30.0; 0.0; 35.0; 45.0; 0.0 | — |
| SECONDARY Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data) |
35.3; 39.7; 40.0; 64.3; 29.4; 31.0 | — |
| SECONDARY Change From Baseline in EQ-5D up to Week 12 - Induction Period |
13.5; 15.3; -0.5 | — |
| SECONDARY Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period |
16.8; 17.4; 12.9; 9.9; 10.0 | — |
| SECONDARY Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period |
-83.3; -86.8; -17.9 | — |
| SECONDARY Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period |
-90.9; -91.2; -78.5; -97.7; -53.7 | — |
| SECONDARY Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period |
59.3; 74.6; 15.3 | — |
| SECONDARY Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance) |
66.1; 70.0; 57.1; 85.7; 0.0 | — |
| SECONDARY Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data) |
43.8; 58.3; 20.0; 73.3; 93.8; 87.5 | — |
| SECONDARY Absolute Change From Baseline for PASI Score After Week 52 (Observed Data) |
-18.7; -15.9; -12.7; -18.1 | — |
| SECONDARY Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) |
25.0; 45.8; 20.0; 60.0; 18.8; 12.5 | — |
| SECONDARY Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies |
1; 2; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- Severity of psoriasis disease meeting all of the following three criteria:
- Psoriasis Area and Severity Index (PASI) score of 12 or greater
- Investigator's Global Assessment (IGA) score of 3 or greater
- Total body surface area (BSA) affected of 10% or greater
- Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
- Hematological abnormalities.
- History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- Pregnant or nursing (lactating) women.
Data sourced from ClinicalTrials.gov (NCT01636687) and the linked publication. 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.