Phase 4
N=258
Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02798211 ↗Enrolled (actual)
258
Serious AEs
6.4%
Results posted
Jan 2021
Primary outcome: Primary: Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 — 51.46; 36.89; 23.08 percentage of participants — p=0.0011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Secukinumab 300 mg (Drug); Secukinumab 150 mg (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 |
51.46; 36.89; 23.08 | 0.0011 sig |
| SECONDARY Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 |
53.06; 44.23; 65.22 | 0.3330 |
| SECONDARY Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 |
63.89; 57.89; 76.92 | 0.1618 |
| SECONDARY Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) |
56.06; 52.24; 82.35 | 0.0125 sig |
| SECONDARY Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) |
62.16; 59.21; 82.05 | 0.0338 sig |
| SECONDARY Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 |
28.16; 24.27; 5.77 | 0.0038 sig |
| SECONDARY Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 |
17.48; 10.68; 1.92 | 0.0243 sig |
| SECONDARY Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 |
64.56; 54.22; 16.28 | <0.0001 sig |
| SECONDARY Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 |
49.37; 36.14; 9.3 | <.0001 sig |
| SECONDARY Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 |
25.32; 18.07; 2.33 | 0.0107 sig |
| SECONDARY Change From Baseline to Week 16 in DAS28-CRP |
-1.39; -1.18; -0.35 | <.0001 sig |
| SECONDARY Change From Baseline to Week 16 in HAQ-DI |
-0.32; -0.24; -0.11 | 0.0107 sig |
Summary
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
- Rheumatoid factor and/or anti-CCP antibodies negative at screening
- A target skin psoriatic lesion and a PASI score of 1 or greater
Exclusion Criteria
- Chest X-ray with evidence of ongoing infectious or malignant process
- Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved
Data sourced from ClinicalTrials.gov (NCT02798211). 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.