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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06100744




Registration number
NCT06100744
Ethics application status
Date submitted
20/10/2023
Date registered
25/10/2023
Date last updated
1/11/2024

Titles & IDs
Public title
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
Scientific title
Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis
Secondary ID [1] 0 0
2023-506026-36-00
Secondary ID [2] 0 0
M23-732
Universal Trial Number (UTN)
Trial acronym
KnaPsAck
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab
Treatment: Drugs - Risankizumab

Experimental: Risankizumab - Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period.

Experimental: Adalimumab - Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period.


Treatment: Drugs: Adalimumab
SC Injection

Treatment: Drugs: Risankizumab
Subcutaneous (SC) Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
Timepoint [1] 0 0
Up to 24 Weeks
Secondary outcome [1] 0 0
Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
Timepoint [1] 0 0
Up to 24 Weeks
Secondary outcome [2] 0 0
Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
Timepoint [2] 0 0
Up to 24 Weeks
Secondary outcome [3] 0 0
Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
Timepoint [3] 0 0
Up to 24 Weeks
Secondary outcome [4] 0 0
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
Timepoint [4] 0 0
Up to Week 24
Secondary outcome [5] 0 0
Change from Baseline in JADAS-27
Timepoint [5] 0 0
Up to Week 24
Secondary outcome [6] 0 0
Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants with Inactive Disease
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
Timepoint [8] 0 0
Up to Week 24
Secondary outcome [9] 0 0
Change from Baseline in cJADAS-27
Timepoint [9] 0 0
Up to Week 24
Secondary outcome [10] 0 0
Change from Baseline in the Pain-Visual Analogue Scale (VAS)
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline
Timepoint [11] 0 0
Up to Week 24
Secondary outcome [12] 0 0
Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
Timepoint [12] 0 0
Up to Week 24
Secondary outcome [13] 0 0
Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline
Timepoint [13] 0 0
Up to Week 24
Secondary outcome [14] 0 0
Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline
Timepoint [14] 0 0
Up to Week 24

Eligibility
Key inclusion criteria
* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 6 months prior to screening.
* Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.
* Have had 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 conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis [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.
* Prior inadequate response to drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23 inhibitor classes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre /ID# 260255 - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
France
State/province [10] 0 0
Nouvelle-Aquitaine
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Nordrhein-Westfalen
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Italy
State/province [14] 0 0
Firenze
Country [15] 0 0
Poland
State/province [15] 0 0
Lodzkie
Country [16] 0 0
Poland
State/province [16] 0 0
Malopolskie
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
England
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.

Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.

Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT06100744
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06100744