Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis (CLARITY)
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|ClinicalTrials.gov Identifier: NCT02826603|
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Secukinumab Drug: Ustekinumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||June 22, 2016|
|Actual Primary Completion Date :||July 9, 2018|
|Actual Study Completion Date :||July 9, 2018|
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Active Comparator: Ustekinumab
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
- Psoriasis Area and Severity Index (PASI) 90 [ Time Frame: Week 12 ]Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per usual standard.
- Investigator's Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Week 12 ]Investigator will assess disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease)
- Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 52 ]Psoriasis Area and Severity Index (PASI) will be assessed.
- Investigator's Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Baseline to Week 52 ]Investigator will assess disease using a validated scale (IGA mod 2011)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 52 ]Clinical safety and tolerability will be assessed up to Week 52 by adverse events monitoring.
- Changes in clinical laboratory variables [Safety and Tolerability] [ Time Frame: Week 52 ]Clinical safety will be assessed up to Week 52 by changes in clinical laboratory variables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826603
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