Risankizumab vs Adalimumab for Juvenile Psoriatic Arthritis
(KnaPsAck Trial)
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must not be taking: Anti-TNF, IL-23 inhibitors
Disqualifiers: Other autoimmune diseases, Rheumatic diseases, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain medications, which might imply that you can continue with them if they are not effective. It's best to discuss this with the trial coordinators.
Is Adalimumab safe for children with juvenile arthritis?
Adalimumab has been studied for safety in children with various forms of juvenile arthritis, psoriasis, and Crohn's disease, showing it is generally safe for long-term use in these conditions.
12345How does the drug Risankizumab differ from other treatments for juvenile psoriatic arthritis?
Risankizumab is unique because it specifically targets and inhibits interleukin-23 (IL-23), a protein involved in inflammation, which is different from other treatments that may target different pathways. This mechanism of action is novel compared to traditional therapies for psoriatic arthritis.
678910Eligibility Criteria
This trial is for children with juvenile Psoriatic Arthritis (jPsA) who have had it for at least 6 months, are experiencing active disease in three or more joints, and haven't responded well to treatments like methotrexate. Kids can't join if they meet certain medical conditions that the study outlines.Inclusion Criteria
I have active disease in 3 or more joints.
My previous treatment for at least 2 months did not work.
I have been diagnosed with juvenile psoriatic arthritis for at least 6 months.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Period 1
Participants are randomized to receive risankizumab or adalimumab for 24 weeks
24 weeks
Regular visits at a hospital or clinic
Treatment Period 2
Participants who respond to the treatment in Period 1 continue the same treatment for another 100 weeks
100 weeks
Regular visits at a hospital or clinic
Follow-up for Adalimumab
Participants who receive adalimumab are followed for safety for 70 days after the last study treatment
10 weeks
Follow-up for Risankizumab
Participants who receive risankizumab are followed for safety for 140 days after the last study treatment
20 weeks
Participant Groups
The trial is testing Risankizumab against Adalimumab, both given as injections based on body weight. Participants will be randomly assigned to one of these drugs for an initial period of 24 weeks and may continue up to another 100 weeks depending on their response.
2Treatment groups
Experimental Treatment
Group I: RisankizumabExperimental Treatment1 Intervention
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.
Group II: AdalimumabExperimental Treatment1 Intervention
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.
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇺🇸 Approved in United States as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Hidradenitis suppurativa
🇨🇦 Approved in Canada as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇯🇵 Approved in Japan as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroHealth Medical Center /ID# 262377Cleveland, OH
UNC Children's Hospital /ID# 259286Chapel Hill, NC
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111Minneapolis, MN
Arkansas Children's Hospital /ID# 258776Little Rock, AR
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study. [2022]This study was conducted to assess the real-world safety and effectiveness of adalimumab in patients with juvenile idiopathic arthritis (JIA).
Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate. [2021]Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. [2019]To evaluate the safety of adalimumab in pediatric patients who participated in clinical trials of juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease.
Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. [2020]To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (JIA) in the STRIVE registry.
Anti-adalimumab antibodies kinetics: an early guide for juvenile idiopathic arthritis (JIA) switching. [2022]To assess the longitudinal production of anti-adalimumab antibody (AAA) and baseline risk factors for this antibody development in juvenile idiopathic arthritis (JIA) patients initiating adalimumab (ADA).
Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. [2022]Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.
Risankizumab to treat moderately to severely active Crohn's disease in adults: an evaluation of trials and data. [2023]Risankizumab is a humanized monoclonal antibody that selectively inhibits interleukin (IL)-23. It is approved for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, and more recently moderate-to-severe Crohn's disease (CD).
Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]Risankizumab-rzaa (Skyrizi®; AbbVie) is a humanized IgG monoclonal antibody directed against interleukin-23p19 (IL-23p19) indicated for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic therapy or phototherapy. Four pivotal Phase III trials: UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent have demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis. This review highlights important findings from these and other clinical trials that have evaluated risankizumab. In addition, we discuss the mechanism of action, pharmacokinetics/pharmacodynamics, dosing recommendations, drug interactions, other potential indications, and ongoing clinical trials.
Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. [2021]Risankizumab (Skyrizi®; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling. Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the EU), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan). In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician's Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term. In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of PASI 90 response rate. In an ongoing open-label extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through > 2.5 years of continuous exposure. Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. In conclusion, risankizumab represents a useful new treatment option for patients with moderate to severe plaque psoriasis.
Risankizumab: First Global Approval. [2020]Risankizumab (Skyrizi®), a humanised IgG monoclonal antibody that targets the p19 subunit of IL-23, was developed by AbbVie in collaboration with Boehringer Ingelheim for the treatment of immunological and inflammatory disorders. In March 2019, risankizumab received its first global approval in Japan for the treatment of adults with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis and erythrodermic psoriasis. Risankizumab has also received approval in the USA, Canada and the EU for the treatment of moderate-to-severe plaque psoriasis, and is in phase 3 development for this indication as well as psoriatic arthritis in several countries worldwide. Phase 2 and 3 clinical evaluation of risankizumab is ongoing in several countries in the treatment of Crohn's disease and ulcerative colitis. Risankizumab is also in phase 2 development for the treatment of atopic dermatitis globally. This article summarizes the milestones in the development of risankizumab leading to this first approval for psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis and erythrodermic psoriasis.