Phase 3
Completed N=1,102
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Source: ClinicalTrials.gov NCT02826603 ↗Enrolled (actual)
1,102
Serious AEs
4.5%
Results posted
Jul 2019
Primary outcomePrimary: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 — 366; 265 Participants — p=<0.0001
◆ Published Evidence
Established
75citations · ~9 / year
Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results).
Summary
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
Linked Publications (4)
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Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results).
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Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).
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Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis.
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Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 |
366; 265 | <0.0001 sig |
| PRIMARY Participants With IGA Mod 2011 0 or 1 at Week 12 |
397; 306 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 |
484; 409 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 |
221; 90 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 |
250; 147 | <0.0001 sig |
| SECONDARY Participants With IGA Mod 2011 0 or 1 at 16 Weeks |
432; 326 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 |
210; 111 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 |
506; 441 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 |
423; 299 | <0.0001 sig |
| SECONDARY Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 |
402; 330 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects must give a written, signed and dated informed consent
- Chronic plaque-type psoriasis present for at least 6 months before randomization
- Moderate to severe plaque psoriasis as defined at randomization by:
- PASI score of ≥12 and
- Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
- IGA mod 2011 ≥3 (based on a scale of 0-4)
- Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
- Topical treatment (including topical corticosteroids) and/or
- Phototherapy and/or
- Previous systemic therapy
Exclusion Criteria
- Forms of psoriasis other than plaque psoriasis
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02826603) 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.