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 (KnaPsAck)

May 11, 2026 updated by: AbbVie

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.

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health - Monash Medical Centre /ID# 260255
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital /ID# 257880
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • British Columbia Children and Women's Hospital and Health Centre /ID# 257884
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children /ID# 257879
  • France
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • Recruiting
        • CHU Bordeaux - Hopital Pellegrin /ID# 258729
    • Paris
      • Le Kremlin-Bicêtre, Paris, France, 94270
        • Recruiting
        • AP-HP - Hopital Bicetre /ID# 258728
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin - Buch /ID# 268803
      • Hamburg, Germany, 22081
        • Recruiting
        • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
    • North Rhine-Westphalia
      • Sankt Augustin, North Rhine-Westphalia, Germany, 53757
        • Recruiting
        • Asklepios Klinik Sankt Augustin /ID# 259106
        • Contact:
          • Site Coordinator
          • Phone Number: +49-2241-249-240
  • Italy
    • Firenze
      • Florence, Firenze, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Universitaria Meyer /ID# 258587
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù /ID# 258869
  • Poland
    • Lesser Poland Voivodeship
      • Cracow, Lesser Poland Voivodeship, Poland, 30-002
        • Recruiting
        • Malopolskie Badania Kliniczne /ID# 258777
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-093
        • Recruiting
        • Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050
    • Silesian Voivodeship
      • Sosnowiec, Silesian Voivodeship, Poland, 41-200
        • Recruiting
        • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-738
        • Recruiting
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe /ID# 257567
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu /ID# 257568
        • Contact:
          • Site Coordinator
          • Phone Number: +34610550263
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
      • Liverpool, United Kingdom, L12 2AP
        • Recruiting
        • Alder Hey Children's NHS Foundation Trust /ID# 262770
    • England
      • Sheffield, England, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital /ID# 258776
        • Contact:
          • Site Coordinator
          • Phone Number: 501-364-3686
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010-2916
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe Dimaggio Children's Hospital Hollywood /ID# 260634
        • Contact:
          • Site Coordinator
          • Phone Number: 954-265-4466
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Riley Hospital for Children /ID# 259067
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
        • Contact:
    • New York
      • New York, New York, United States, 10032-3729
        • Recruiting
        • Columbia University Medical Center /ID# 262587
        • Contact:
          • Site Coordinator
          • Phone Number: 212-305-4308
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Boston Childrens Health Physicians /ID# 258061
        • Contact:
          • Site Coordinator
          • Phone Number: 914-504-0152
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina - Children's Hospital /ID# 259286
        • Contact:
          • Site Coordinator
          • Phone Number: 919-504-6650
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center /ID# 262377
    • Texas
      • Austin, Texas, United States, 78757-7571
        • Recruiting
        • Child Neurology Consultants of Austin /ID# 260562
        • Contact:
          • Site Coordinator
          • Phone Number: 512-494-4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 treatments in the anti-TNF or IL-23 inhibitor classes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • Skyrizi
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.
Drug: Adalimumab
SC Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 24 Weeks
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.
Up to Week 144

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
Up to 24 Weeks
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
Time Frame: Up to Week 24
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.
Up to Week 24
Change from Baseline in JADAS-27
Time Frame: Up to Week 24
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.
Up to Week 24
Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
Time Frame: Week 24
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.
Week 24
Percentage of Participants with Inactive Disease
Time Frame: Week 24
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.
Week 24
Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
Time Frame: Up to Week 24
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.
Up to Week 24
Change from Baseline in cJADAS-27
Time Frame: Up to Week 24
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.
Up to Week 24
Change from Baseline in the Pain-Visual Analogue Scale (VAS)
Time Frame: Week 24
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.
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
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.
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
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.
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
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.
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
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.
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M23-732
  • 2023-506026-36-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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