Comparison of secukinumab versus guselkumab in clearing psoriatic plaques refractory to ustekinumab
- Conditions
- Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001048-70-DE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1) Signed informed consent must be obtained prior to participation in the study
2) Men or women = 18 years of age at the time of consent
3) Chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria:
- ustekinumab administered at a dose equal or higher than that on the label for at least 24 weeks. The last administration must be at least 12 weeks before randomization
- absolute psoriasis area and severity index (PASI) score of 1-10 at Screening
4) Presence of at least 1 refractory skin plaque, defined by a total clinical score (TCS) of at least 6 and severity score of at least 2 or 3 (moderate) for each individual item, with an area = 10 cm2 at Screening and Baseline (Day 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at Screening or Baseline
2) Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Screening or Baseline
3) Previous treatment with more than one tumor necrosis factor alpha (TNFa) inhibitors or with IL-17A (including secukinumab), IL-17R or IL-23 (including guselkumab) inhibitors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the superiority of secukinumab over guselkumab in controlling clinical activity in psoriatic plaques resistant to treatment with ustekinumab.;Secondary Objective: Not applicable.;Primary end point(s): Proportion of subjects whose plaque achieves clear” or almost clear” status (TCS = 0-2, see Section 8.3.1 of the protocol) by 16 weeks of treatment with secukinumab or guselkumab;Timepoint(s) of evaluation of this end point: 16 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable<br>