Efficacy and Safety Evaluation of JNJ-77242113 in Biologic-Experienced Patients with Active Psoriatic Arthritis: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study

Trial ID: 2024-517284-23-00
Protocol: 77242113PSA3002
Sponsor: Janssen Cilag International

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Diseases & Conditions

Psoriatic arthropathy

Objectives

The primary objective of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study is to evaluate the **efficacy** of JNJ-77242113 at doses of 200 mg and 400 mg compared to placebo in participants with active **Psoriatic Arthritis** (PsA). The assessment focuses on the reduction of signs and symptoms of PsA at Week 16. This objective is clinically relevant as it aims to determine the potential of JNJ-77242113 to improve patient outcomes in those who have previously been treated with biologics, addressing a significant need for effective management options in this patient population.

Participants

The clinical trial involves a total of **321 participants** diagnosed with **Active Psoriatic Arthritis**. The study population includes both male and female subjects, aged 18 years and older, who have been diagnosed with Psoriatic Arthritis for at least three months prior to the study. Participants were selected based on specific criteria, including having active Psoriatic Arthritis with at least three swollen and three tender joints, and a C-reactive protein level of 0.1 mg/dL or higher. Additionally, participants must have active plaque psoriasis or nail changes consistent with psoriasis. The trial includes individuals who have previously been treated with at least one biologic agent for Psoriatic Arthritis or psoriasis, with documented reasons for discontinuation. Lifestyle considerations include the stability of any non-biologic DMARDs, NSAIDs, or oral corticosteroids used by participants, ensuring no serious toxic side effects. The trial population is not limited to any specific gender, and it includes vulnerable populations, ensuring a comprehensive evaluation of the treatment's efficacy across diverse demographic groups.

Plans and Procedures

The clinical trial is a **Phase 3**, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of **JNJ-77242113** in biologic-experienced participants with active **psoriatic arthritis**. The trial aims to assess the reduction in signs and symptoms of psoriatic arthritis by comparing JNJ-77242113 at doses of 200 mg and 400 mg against a placebo at Week 16. The primary endpoint is the American College of Rheumatology (ACR) 20 response at Week 16. The trial is expected to commence recruitment on May 1, 2025, and conclude by October 18, 2028.

Participants will be involved in the study for a maximum treatment period of 100 weeks. The trial includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age, diagnosis, and previous treatment history; baseline visits to establish initial health metrics; and regular follow-up visits to monitor progress and collect data on efficacy and safety. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any post-trial care is arranged.

Inclusion criteria require participants to be at least 18 years old, have a diagnosis of psoriatic arthritis for at least three months, and exhibit active disease as defined by specific clinical markers. Participants must have been previously treated with at least one biologic agent for psoriatic arthritis or psoriasis, with documented reasons for discontinuation. Stable use of certain non-biologic DMARDs and NSAIDs is permitted under specified conditions. Exclusion criteria are not explicitly detailed in the provided data.

Participants may be withdrawn from the study if they experience significant adverse effects, fail to adhere to the study protocol, or if the investigator deems it necessary for their safety. The study is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants throughout the trial duration.

Treatment

The clinical trial involves the administration of **JNJ-77242113**, an experimental medication formulated as a **film-coated tablet**. This investigational drug is designed for **oral use** and is being evaluated for its efficacy and safety in treating participants with active **psoriatic arthritis**. The active substance in JNJ-77242113 is a protein of other origin, and the medication is provided by Janssen-Cilag International N.V. Participants in the trial will receive JNJ-77242113 at dosages of either 200 mg or 400 mg. The treatment period is set for a maximum of 100 days, with the dosing schedule and participant compliance being closely monitored throughout the study.

In addition to the experimental treatment, the study includes a **placebo** group to serve as a comparator. The placebo is administered in the form of a tablet, identical in appearance to the active medication but devoid of the active substance. This placebo control is essential for maintaining the double-blind nature of the trial, ensuring that neither the participants nor the investigators are aware of the treatment assignments. The placebo is also administered orally, following the same schedule as the active treatment, to accurately assess the efficacy of JNJ-77242113 against a non-active comparator.

Efficacy

The efficacy of JNJ-77242113 in the treatment of active **Psoriatic Arthritis** (PsA) will be assessed in a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the American College of Rheumatology (ACR) 20 response at Week 16. This endpoint measures the percentage of participants achieving at least a 20% improvement in tender and swollen joint counts, as well as other criteria related to PsA symptoms.

Participants will be administered JNJ-77242113 at doses of 200 mg and 400 mg, with efficacy assessments conducted at the specified timepoint of Week 16. The trial will include biologic-experienced participants with active PsA, characterized by at least 3 swollen and 3 tender joints, and a C-reactive protein (CRP) level of ≥0.1 mg/dL at screening. The study aims to evaluate the reduction in signs and symptoms of PsA, providing a comprehensive analysis of the treatment's impact on disease activity.

Inclusion and Exclusion Criteria

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Inclusion Criteria

At least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age.
Have a diagnosis of PsA for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.
Have active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline -and b. C-reactive protein (CRP) ≥0.1 mg/dL at screening from the central laboratory. NOTE: A one-time repeat assessment of CRP level is allowed during the screening phase and the Investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.
Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis with at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis.
Have active PsA despite current or previous use of ≥1 of the following (criterion modified per Amendment 4): a. Non-biologic DMARD therapy o Defined as taking a non-biologic DMARD (limited to MTX, SSZ, HCQ, or LEF) for at least 12 weeks before first administration of study intervention, or evidence of non-biologic DMARD intolerance. b. Apremilast therapy o Defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 12 weeks before first administration of study intervention, or evidence of apremilast intolerance. c. Biologic-agent o Limited to only 1 biologic agent for PsA or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented. oIf the reason for discontinuation is lack of benefit to a biologic therapy, this is defined as: lack of benefit, as assessed by the treating physician, after at least 12 weeks of abatacept, etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar), at least 14 weeks of infliximab (or biosimilar), or 16 weeks of anti-IL-17 therapy at an approved dose for PsA or psoriasis. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or PsA or psoriasis disease activity. o If the reason for discontinuation is intolerance to a biologic therapy, this is defined as: Intolerance to a biologic therapy for PsA or psoriasis, as assessed by the treating physician. o If the reason for discontinuation is other than the above, the reason for discontinuation must be specified and documented and it may include financial reasons, sub-optimal dosing, etc. NOTES: o Switching from an original biologic to the biosimilar of the same original biologic or vice versa, is considered as use of 1 biologic agent for PsA or psoriasis. o Refer to Exclusion Criterion #29 for washout periods before first administration of study intervention for biologic experienced participants.
If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 12 weeks prior and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a. If using MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg/week. b. If receiving SSZ, the dose must be stable and ≤3 g/day c. If receiving HCQ, the dose must be stable and ≤400 mg/day d. If receiving LEF, the dose must be stable and ≤20 mg/day (NOTE: use ofLEF and MTX combination therapy is not allowed) If using apremilast at baseline, participants must be on a stable dose and ≤30 mg twice daily for at least 12 weeks before first administration of study intervention. If currently not using apremilast, the participant must not have received apremilast within 4 weeks before first administration of study intervention. If using NSAIDs for PsA at baseline, participants must be on a stable dose for at least 2 weeks before first administration of study intervention. The maximum allowed dose is the marketed dose approved in the country where the study is being conducted. If currently not using NSAIDs for PsA, must not have received NSAIDs for PsA within 2 weeks before first administration of study intervention. If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study intervention. If currently not using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks before first administration of study intervention.

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Exclusion Criteria

Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances.
Currently has a malignancy or has a history of malignancy within 5 years prior to screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration).
Has known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients (refer to the IB).
Has unstable cardiovascular disease, defined as a clinical deterioration (eg, unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 12 weeks prior to screening or a cardiac hospitalization within the last 12 weeks prior to screening.
Has other inflammatory diseases that might confound the evaluations of benefit of JNJ-77242113 therapy, including but not limited to RA, systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).
Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator’s opinion, would have potential to interfere with efficacy assessments.
Restricted or Prohibited Medication or Class of Medications: Has previously received the following agents for PsA or psoriasis: - JAK inhibitors, -TYK inhibitors (such as deucravacitinib) Restriction Duration: Ever (ie, any previous use is exclusionary)
Restricted or Prohibited Medication or Class of Medications: Has previously received the following biologic DMARDs for PsA or psoriasis: - Anti-IL-23 agents or biosimilars; - Anti-IL-12/23 agents or biosimilars. Restriction Duration: Ever (ie, any previous use is exclusionary)
Restricted or Prohibited Medication or Class of Medications: Has previously received the following biologic agents for PsA or psoriasis: - Anti-TNFα agents or biosimilars, anti-IL-17 agents or biosimilars, or abatacept or biosimilars. Restriction Duration: 30 days or 5 half-lives (whichever is longer) prior to the first administration of study intervention

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
Bulgaria	Not Recruiting	14 Apr 2025	24
Czechia	Recruiting	14 Apr 2025	30
Denmark	Recruiting	14 Apr 2025	15
Germany	Recruiting	14 Apr 2025	40
Hungary	Recruiting	14 Apr 2025	38
Italy	Recruiting	14 Apr 2025	32
Poland	Recruiting	14 Apr 2025	182
Romania	Recruiting	14 Apr 2025	15
Spain	Recruiting	14 Apr 2025	25