E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic arthritis |
Artrite Psoriática |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis is an inflammatory disease where the immune system attacks healthy joints and skin causing pain, swelling, and stiffness in the joints, and red scaly patches on the skin. |
Artrite psoriática é uma doença inflamatória, que o sistema imunitário ataca as articulações saudáveis e a pele, causando dor, inchaço, rigidez nas articulações, manchas vermelhas e escamosas na pele. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis. |
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E.2.2 | Secondary objectives of the trial |
Period 1 (Double Blind Period): To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis. Period 2 Double Blind: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit. • Subject has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline. • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit. o Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or csDMARD therapy(ies). |
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E.4 | Principal exclusion criteria |
• Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study. • Subject has a known hypersensitivity to risankizumab. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 response at Week 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24; 2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a BSA ≥3% at Baseline); 3. Proportion of subjects achieving ACR20 at Week 16. 4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24; 5. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24; 6. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24. Other secondary endpoints without multiplicity adjustment are: 1. Proportion of subjects achieving ACR50 response at Week 24; 2. Proportion of subjects achieving ACR70 response at Week 24. 3. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline. 4. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 64 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Chile |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
Israel |
Italy |
Netherlands |
Poland |
Portugal |
Puerto Rico |
Singapore |
South Africa |
Spain |
Sweden |
Switzerland |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last protocol contact or last protocol follow-up of the last subject, whichever is longer. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 72 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 72 |