Phase 3
N=202
Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02474082 ↗Enrolled (actual)
202
Serious AEs
4.0%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24 — 89.52; 33.68 Percentage of participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Fumaric acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24 |
89.52; 33.68 | <.0001 sig |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
9.5; 1.1; 37.1; 6.3; 63.8; 10.5 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20 |
0; 0; 5.7; 0; 24.8; 0 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
0; 0; 1.9; 0; 2.9; 0 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
23.8; 23.2; 20.1; 22.5; 17.0; 22.1 | — |
| SECONDARY Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
1.8; 4.1; 3.6; 8.2; 5.4; 10.2 | — |
| SECONDARY Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
1.8; 0; 1.8; 2.0; 5.4; 2.0 | — |
| SECONDARY Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
1.8; 0; 1.8; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
1.8; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
0; 0; 0; 0; 18; 8 | — |
| SECONDARY Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
0; 0; 5.7; 0; 13.3; 1.1 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
13.9; 16.3; 10.5; 15.3; 8.4; 14.6 | — |
| SECONDARY Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24 |
0; 0; 3.8; 1.1; 7.6; 0 | — |
| SECONDARY Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24 |
38.1; 26.1; 41.2; 36.4; 24.5; 19.6 | — |
Summary
This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.
Eligibility Criteria
Inclusion Criteria
- Men or women must be at least 18 years of age at the time of screening
- Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
- PASI score of >10
- Affected body surface area (BSA) > 10%
- DLQI >10
- Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.
Exclusion Criteria (abbreviated):
- Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline
- Ongoing use of other prohibited psoriasis and non-psoriasis treatment.
- Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations
- Patients with severe liver diseases
- Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers
- Patients with severe kidney diseases or serum creatinine above 1 x ULN
- Patients with known hematological disease or lab abnormalities
- Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)
Data sourced from ClinicalTrials.gov (NCT02474082). 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.