RISANKIZUMAB for Juvenile psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Subjects must have a diagnosis of jPsA according to ILAR criteria for at least 3 months prior to Screening.\n- Active disease in ≥ 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, limitation of motion with pain or tenderness or both meet the criteria for an active arthritic joint.\n- Subject must have demonstrated an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following csDMARDs: MTX, sulfasalazine, leflunomide, or hydroxychloroquine."}

Exclusion criteria

• {"criterion_text":"- Subjects have any other autoimmune disease, rheumatic disease (including systemic JIA, rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.","definition_or_measurement_approach":"Achievement of JIA-ACR 30 response at Week 24 (as stated)."}

Secondary endpoints

• {"endpoint_text":"- Achievement of JIA-ACR 50/70/90 response at Week 24","definition_or_measurement_approach":"Achievement of JIA-ACR 50/70/90 response at Week 24 (as stated)."}
• {"endpoint_text":"- Percent change from Baseline in individual components of JIA-CRV at Week 24.","definition_or_measurement_approach":"Percent change from Baseline in individual components of JIA-CRV at Week 24 (as stated)."}
• {"endpoint_text":"- Change from Baseline in JADAS-10 and JADAS-27 at Week 24.","definition_or_measurement_approach":"Change from Baseline in JADAS-10 and JADAS-27 at Week 24 (as stated)."}
• {"endpoint_text":"- Achievement of MDA at Week 24 (defined as JADAS-10 of ≤6)","definition_or_measurement_approach":"MDA at Week 24 defined as JADAS-10 ≤ 6 (definition provided in endpoint)."}
• {"endpoint_text":"- Achievement of inactive disease at Week 24 (defined as JADAS-10 of ≤2.7)","definition_or_measurement_approach":"Inactive disease at Week 24 defined as JADAS-10 ≤ 2.7 (definition provided in endpoint)."}
• {"endpoint_text":"- Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24.","definition_or_measurement_approach":"Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24 (as stated)."}
• {"endpoint_text":"- Change from Baseline in the Pain-VAS at Week 24","definition_or_measurement_approach":"Change from Baseline in the Pain-VAS at Week 24 (as stated)."}
• {"endpoint_text":"- In subjects with PsO (at least 3% BSA at Baseline), achievement of PASI 75/90 at Week 24","definition_or_measurement_approach":"For subjects with PsO (≥3% BSA at Baseline), achievement of PASI 75/90 at Week 24 (population restriction noted in endpoint)."}
• {"endpoint_text":"- In subjects with PsO (at least 3% BSA at Baseline), achievement of the sPGA of PsO of 'clear' or 'almost clear' (0/1) at Week 24.","definition_or_measurement_approach":"For subjects with PsO (≥3% BSA at Baseline), achievement of sPGA 0/1 at Week 24 (population restriction noted)."}
• {"endpoint_text":"- In subjects with PsO (at least 3% BSA at Baseline), change from Baseline in CDLQI at Week 24.","definition_or_measurement_approach":"For subjects with PsO (≥3% BSA at Baseline), change from Baseline in CDLQI at Week 24 (population restriction noted)."}

Methods

• Doctor-to-caregiver email templates (country-specific) — documents exist for Germany, Italy, France, Spain indicating recruitment via clinicians contacting caregivers.
• Doctor-to-caregiver letter templates (country-specific) — country-specific letter templates for clinician-to-caregiver recruitment.
• Patient–caregiver brochures (country-specific) — educational brochures for patients/caregivers in multiple countries (Germany, Italy, France, Poland, Spain).
• Patient flyers (country-specific) — short recruitment flyers for patients/caregivers.
• Informational study website (country-specific) — documented informational study website materials for recruitment.
• Animated ICF video/frames with script (German and Spanish documented) — use of animated video materials to inform subjects/caregivers.
• Centralized recruitment support by Qd Solutions Inc. (listed with duty 'Recruitment').
• E-PRO tools (Medable) and electronic recruitment/communication platforms (Veeva, Medable) referenced in third‑party roles.

Germany

Earliest CTIS Part Ii Submission Date

19-02-2024

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

731

Number Of Sites

3

Number Of Participants

4

Italy

Earliest CTIS Part Ii Submission Date

19-02-2024

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

731

Number Of Sites

3

Number Of Participants

4

France

Earliest CTIS Part Ii Submission Date

02-02-2024

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

774

Number Of Sites

2

Number Of Participants

4

Poland

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

22-02-2026

Processing Time Days

730

Number Of Sites

5

Number Of Participants

6

Spain

Earliest CTIS Part Ii Submission Date

16-02-2024

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

735

Number Of Sites

2

Number Of Participants

6

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Iqvia Biotech Limited

Responsibilities

sponsorDuties code 3 (clinical trial services/CTMS); contact eu_clinical_trials_information@iqvia.com

Name

Qd Solutions Inc.

Responsibilities

Recruitment

Name

WCG Clinical Inc.

Responsibilities

Adjudication

Name

Labcorp Central Laboratory Services LP / S.a.r.l.

Responsibilities

Central laboratory services; contacts provided

Third parties

• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code 4 (contact and laboratory services); email rachael.lydon@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"sponsorDuties code 4 (laboratory services); email ctasubmissions@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"Recruitment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes 6 and 7 (data/platform support)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"E-PRO and platform services (E-PRO); sponsorDuties code 7","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"sponsorDuties code 3 (clinical trial services/CTMS); email eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Adjudication","organisation_type":"Pharmaceutical company"}