E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis. |
Psoriatični artritis |
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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. |
Psoriatični artritis je vnetna bolezen, pri kateri imunski sistem napade zdrave sklepe in kožo, ki povzroča bolečino, oteklino in togost v sklepih in rdeče luskaste lise na koži. |
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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 | 20.0 |
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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Primerjava učinkovitosti 150 mg risankizumaba in placeba za zdravljenje znakov in simptomov PsA v študijski populaciji |
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E.2.2 | Secondary objectives of the trial |
Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis.
Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1.
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1. obdobje (dvojno slepo): 1. Primerjava učinkovitosti 150 mg risankizumaba in placeba za zavrtje napredovanja radiografsko ocenjene strukturne okvare v študijski populaciji.
2. Primerjava varnosti in prenašanja 150 mg risankizumaba in placeba pri bolnikih s psoriatičnim artritisom.
2. obdobje: Ocena dolgoročne varnosti, prenašanja in učinkovitosti 150 mg risankizumaba pri preiskovancih, ki so dokončali 1. obdobje.
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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 the Screening Visit.
• Subject has active disease at 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.
• Presence of either at Screening:
1. ≥ 1 erosion on radiograph as determined by central imaging review or;
2. hs-CRP ≥ 3.0 mg/L.
• Subject has demonstrated an inadequate response to previous or current treatment with at least 1 csDMARD OR subject must have an intolerance to or contraindication for csDMARDs as determined by the investigator. |
• Klinična diagnoza PsA s pojavom simptomov vsaj 6 mesecev pred presejalnim obiskom in izpolnjevanje razvrstitvenih meril za PsA (CASPAR) na presejalnem obisku.
• Preiskovanec ima na izhodiščnem obisku aktivno bolezen
• Diagnoza aktivne psoriaze v plakih z vsaj enim psoriatičnim plakom s premerom ≥ 2 cm ali spremembe nohtov, ki se skladajo s psoriazo, na presejalnem obisku.
• Ob presejanju prisotnost enega od naslednjega dvojega:
1. ≥ 1 erozije na radiografskem posnetku, ugotovljeno s centralnim pregledom posnetka, ali
2. hsCRP ≥ 3,0 mg/l.
• Preiskovanec mora imeti dokazan nezadosten odziv na predhodno ali trenutno zdravljenje z vsaj 1 ksIA ali mora imeti preiskovanec intoleranco ali kontraindikacijo za ksIA, kot to presodi raziskovalec
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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.
• Subject has previous treatment with biologic agent. |
• Preiskovanec je, po mnenju raziskovalca, iz kakršnega koli razloga, neprimeren kandidat za študijo.
• Preiskovanec ima znano preobčutljivost na Risankizumab.
• Preiskovanec je predhodno zdravljen z biološkimi zdravili |
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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 (ACR20) at Week 24. |
Primarni opazovani dogodek je delež preiskovancev, ki po 24 tednih dosežejo odziv ACR (American College of Rheumatology) 20.
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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. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24;
4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;
5. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F, US)/ modified Nail Psoriasis Severity Index (mNAPSI, ex-US) at Week 24 (in the subset of subjects with nail psoriasis at Baseline); Note: PGA-F and mNAPSI assessments will be obtained in all patients, whether US or ex-US.
6. Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24 (in the subset of subjects with enthesitis at the LEI sites at Baseline);
7. Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24 (in the subset of subjects with dactylitis at Baseline);
8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24;
9. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24. |
1. Sprememba indeksa HAQ-DI (Health Assessment Questionnaire – Disability Index) od izhodišča do 24. tedna
2. Delež preiskovancev, ki po 24 tednih dosežejo odziv PASI (Psoriasis Area Severity Index) 90 (v podskupini preiskovancev z izhodiščno prizadetostjo ≥ 3 % TP)
3. Sprememba prilagojene celotne Sharpove ocene (PsA-mTSS) od izhodišča do 24. tedna
4. Delež bolnikov, ki po 24 tednih dosežejo minimalno aktivnost bolezni (MDA – Minimal Disease Activity)
5. Sprememba zdravnikove globalne ocene nohtov na rokah (PGA-F, v ZDA)/prilagojenega indeksa izrazitosti psoriaze nohtov (mNAPSI, zunaj ZDA) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev, ki so izhodiščno imeli psoriazo nohtov). Opomba: Oceni PGA-F in mNAPSI bosta narejeni za vse bolnike, najsi bo v ZDA ali zunaj ZDA.
6. Sprememba indeksa LEI (Leeds Enthesitis Index) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev z izhodiščno prisotnim entezitisom na mestih LEI)
7. Sprememba indeksa LDI (Leeds Dactylitis Index) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev z izhodiščno prisotnim daktilitisom)
8. Sprememba povzetka telesne komponente (PCS – Physical Component Summary) vprašalnika SF 36 (Short Form Health Survey s 36 postavkami) po 24 tednih v primerjavi z izhodiščem
9. Sprememba ocene FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) po 24 tednih v primerjavi z izhodiščem. |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 144 |
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 |
Bosnia and Herzegovina |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Croatia |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Poland |
Portugal |
Puerto Rico |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
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. |
LVLS |
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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 |