Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW)
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ClinicalTrials.gov Identifier: NCT03553823 |
Recruitment Status :
Completed
First Posted : June 12, 2018
Results First Posted : February 25, 2021
Last Update Posted : October 11, 2021
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Tracking Information | |||||||
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First Submitted Date ICMJE | May 15, 2018 | ||||||
First Posted Date ICMJE | June 12, 2018 | ||||||
Results First Submitted Date ICMJE | January 21, 2021 | ||||||
Results First Posted Date ICMJE | February 25, 2021 | ||||||
Last Update Posted Date | October 11, 2021 | ||||||
Actual Study Start Date ICMJE | January 14, 2019 | ||||||
Actual Primary Completion Date | January 28, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2) [ Time Frame: 16 week ] Total clinical score: number (%) of subjects who responded at Week 16 (FAS)
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Original Primary Outcome Measures ICMJE |
Proportion of subjects whose plaque achieves "clear" or "almost clear" status (TCS = 0-2) [ Time Frame: 16 week ] To demonstrate the superiority of secukinumab over guselkumab in controlling clinical activity in psoriatic plaques resistant to treatment with ustekinumab
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||
Brief Title ICMJE | Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab | ||||||
Official Title ICMJE | A 16-week Randomized, Open-label, Multicenter Study to Assess the Superiority of Secukinumab Over Guselkumab in the Complete Treatment of Ustekinumab Resistant Psoriatic Plaques | ||||||
Brief Summary | The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective IL-23 inhibitor ustekinumab (blocker of p40 subunit, shared by IL-12 and IL 23). | ||||||
Detailed Description | This was a 16-week, randomized, open-label, parallel-group, active-control, Phase 2a study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab. Forty subjects will be randomized 1:1 and treated for 16 weeks. In each patient, a target active refractory skin plaque (TCS ≥6) is described and biopsied at baseline and at study end. The objective of the study was to assess the superiority of secukinumab over guselkumab in achieving clear/almost clear status (TCS 0-2) of the target plaques; and to describe the molecular mechanisms behind this difference | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This was a 16-week, randomized, open-label, parallel-group, active-control study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab. Masking: Single (Outcomes Assessor)Masking Description: Blinded outcome assessor assessed subjects on each visit for target plaque TCS, PASI, IGA, BSA, ppIGA, PSSI, NAPS. Primary Purpose: Treatment
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Condition ICMJE | Chronic Plaque-type Psoriasis | ||||||
Intervention ICMJE | Procedure: Skin biopsies
At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS ≥ 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | January 28, 2020 | ||||||
Actual Primary Completion Date | January 28, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria-:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, Germany, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03553823 | ||||||
Other Study ID Numbers ICMJE | CAIN457A2403 2018-001048-70 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Novartis | ||||||
Verification Date | October 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |