Juvenile Psoriatic ArthritisPhase 3NCT06100744
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
A Phase 3 study testing Adalimumab and Risankizumab in people with Juvenile Psoriatic Arthritis, run by AbbVie at 34 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Juvenile Psoriatic Arthritis
- What is being tested?
- Adalimumab and Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 34 sitesin 9 countries
- Study dates
- 8 Jul 2024to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 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.
Who cannot join
- 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 treatments in the anti-TNF or IL-23 inhibitor classes.
Trial locations and contacts
34 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 9 countries
United States12 sites, 12 recruiting
- Recruiting
Child Neurology Consultants of Austin /ID# 260562
Austin, Texas, 78757-7571
Site Coordinator, 512-494-4000
- Recruiting
University of North Carolina - Children's Hospital /ID# 259286
Chapel Hill, North Carolina, 27514
Site Coordinator, 919-504-6650
- Recruiting
MetroHealth Medical Center /ID# 262377
Cleveland, Ohio, 44109
- Recruiting
Cleveland Clinic - Cleveland /ID# 276655
Cleveland, Ohio, 44195
- Recruiting
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, 33021
Site Coordinator, 954-265-4466
- Recruiting
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, 46202
- Recruiting
Arkansas Children's Hospital /ID# 258776
Little Rock, Arkansas, 72202
Site Coordinator, 501-364-3686
- Recruiting
All X Ray Diagnostic Services Corp /ID# 278523
Miami, Florida, 33126
Site Coordinator, (305) 445-9462, thalialopez@allxray.com
- Recruiting
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis, Minnesota, 55454
Site Coordinator, rheum-research@umn.edu
- Recruiting
Columbia University Medical Center /ID# 262587
New York, New York, 10032-3729
Site Coordinator, 212-305-4308
- Recruiting
Boston Childrens Health Physicians /ID# 258061
Valhalla, New York, 10595
Site Coordinator, 914-504-0152
- Recruiting
Childrens National Medical Center /ID# 259284
Washington D.C., District of Columbia, 20010-2916
Site Coordinator, qyu@childrensnational.org
Poland5 sites, 5 recruiting
- Recruiting
Malopolskie Badania Kliniczne /ID# 258777
Cracow, Lesser Poland Voivodeship, 30-002
- Recruiting
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
Lodz, Łódź Voivodeship, 91-738
- Recruiting
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
Lublin, Lublin Voivodeship, 20-093
- Recruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058
Sosnowiec, Silesian Voivodeship, 41-200
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. /ID# 277050
Warsaw, Masovian Voivodeship, 02-637
Canada3 sites, 3 recruiting
- Recruiting
Alberta Children's Hospital /ID# 257880
Calgary, Alberta, T3B 6A8
- Recruiting
Hospital for Sick Children /ID# 257879
Toronto, Ontario, M5G 1X8
- Recruiting
British Columbia Children and Women's Hospital and Health Centre /ID# 257884
Vancouver, British Columbia, V6H 3N1
Germany3 sites, 3 recruiting
- Recruiting
Helios Klinikum Berlin - Buch /ID# 268803
Berlin, 13125
Site Coordinator, kinderklinik.berlin-buch@helios-gesundheit.de
- Recruiting
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
Hamburg, 22081
- Recruiting
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin, North Rhine-Westphalia, 53757
Site Coordinator, +49-2241-249-240
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence, Firenze, 50139
- Recruiting
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753
Milan, Milano, 20122
- Recruiting
Ospedale Pediatrico Bambino Gesu /ID# 258869
Rome, Roma, 00165
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol, BS2 8BJ
- Recruiting
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool, L12 2AP
- Recruiting
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield, England, S10 2TH
France2 sites, 2 recruiting
- Recruiting
Chu Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux, New Aquitaine, 33076
- Recruiting
AP-HP - Hopital Bicetre /ID# 258728
Le Kremlin-Bicêtre, Paris, 94270
Spain2 sites, 2 recruiting
- Recruiting
Hospital Sant Joan de Deu /ID# 257568
Esplugues de Llobregat, Barcelona, 08950
- Recruiting
Hospital Universitario y Politecnico La Fe /ID# 257567
Valencia, 46026
Australia1 site, 1 recruiting
- Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 260255
Clayton, Victoria, 3168
About this study
Official 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
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.
Read more
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.
- Conditions
- Juvenile Psoriatic Arthritis
- Being tested
- Adalimumab, Risankizumab
- Keywords
- Juvenile Psoriatic Arthritis, Psoriatic Arthritis, Risankizumab, ABBV-066, Adalimumab
- Medical subject headings
- Arthritis, Juvenile, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
SC Injection
RisankizumabDrug
Also called ABBV-066, Skyrizi
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | 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. Receives: Drug: Risankizumab |
| Adalimumab | Experimental | 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. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
The JIA-ACR 30 response is defined as a >= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without >30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI).
Measured: Up to 24 Weeks
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Week 144
Secondary outcomes (14)
Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
The JIA-ACR 50 response is defined as a >= 50% improvement of at least 3 or more of the 6 JIA-CRVs without >50% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
Measured: Up to 24 Weeks
Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
The JIA-ACR 70 response is defined as a >= 70% improvement of at least 3 or more of the 6 JIA-CRVs without >70% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
Measured: Up to 24 Weeks
Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
The JIA-ACR 90 response is defined as a >= 90% improvement of at least 3 or more of the 6 JIA-CRVs without >90% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
Measured: Up to 24 Weeks
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and high sensitivity C-reactive protein (hsCRP). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
Measured: Up to Week 24
Change from Baseline in JADAS-27
JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and hsCRP. JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
Measured: Up to Week 24
Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
MDA is defined as JADAS-10 of <= 6. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
Measured: Week 24
Percentage of Participants with Inactive Disease
Inactive disease is defined as JADAS-10 of <= 2.7. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
Measured: Week 24
Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
Measured: Up to Week 24
Change from Baseline in cJADAS-27
cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
Measured: Up to Week 24
Change from Baseline in the Pain-Visual Analogue Scale (VAS)
Participants assessed their pain using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 with no pain being indicated by 0 and severe pain by 100.
Measured: Week 24
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
The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
Measured: Up to Week 24
Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
Measured: Up to Week 24
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
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions, with a lower score indicating less body coverage.
Measured: Up to Week 24
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
The CDLQI is a 10-item questionnaire used to assess the impact of dermatologic disease symptoms and treatment on quality-of-life (QOL), with a higher score indicating greater impairment of QOL. The CDLQI has been validated for use in participants 4 to 16 years old.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start8 Jul 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100744
- Sponsor's protocol ID
- M23-732
- Other IDs
- 2023-506026-36-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06100744
- Acronym / sponsor ID
- M23-732
- Conditions
- Juvenile Psoriatic Arthritis
- Keywords
- Juvenile Psoriatic Arthritis, Psoriatic Arthritis, Risankizumab, ABBV-066, Adalimumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: RisankizumabParticipants 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. |
| Adalimumab | Experimental | Drug: AdalimumabParticipants 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 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.
Key exclusion criteria (2 listed)
- 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 treatments in the anti-TNF or IL-23 inhibitor classes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabSC Injection | Drug | Adalimumab |
| RisankizumabAlso: ABBV-066, SkyriziSubcutaneous (SC) Injection | Drug | Risankizumab |
Primary outcome
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
Time frame: Up to 24 Weeks
The JIA-ACR 30 response is defined as a >= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without >30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI).
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 144
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
14 secondary outcomes
Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
Time frame: Up to 24 Weeks
Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
Time frame: Up to 24 Weeks
Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
Time frame: Up to 24 Weeks
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
Time frame: Up to Week 24
Change from Baseline in JADAS-27
Time frame: Up to Week 24
Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
Time frame: Week 24
Percentage of Participants with Inactive Disease
Time frame: Week 24
Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
Time frame: Up to Week 24
Change from Baseline in cJADAS-27
Time frame: Up to Week 24
Change from Baseline in the Pain-Visual Analogue Scale (VAS)
Time frame: Week 24
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
Time frame: Up to Week 24
Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
Time frame: Up to Week 24
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
Time frame: Up to Week 24
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
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
34 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab and Risankizumab in people with Juvenile Psoriatic Arthritis, run by AbbVie at 34 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Poland, Canada, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30) (time frame: Up to 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.