This study is open to adults with active psoriatic arthritis who have tender and swollen joints. The purpose of this study is to find out whether a medicine called BI 730357 helps to reduce symptoms and to prevent damage to joints. Three different doses of BI 730357 are tested. Participants are put into 4 groups by chance. Participants in 3 of the 4 groups take BI 730357. Participants in the fourth group take placebo. Participants take BI 730357 or placebo as tablets once a day. Placebo tablets look like BI 730357 tablets but do not contain any medicine. Participants are in the study for about 4.5 months. During this time, they visit the study site about 8 times. At these visits, doctors check whether the swelling of inflamed joints has changed. The results between the BI 730357 and placebo groups are then compared. Doctors also regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
American College of Rheumatology (ACR) 20 response at week 12
ACR 20 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.
Time frame: at week 12
ACR 50 response at Week 12
ACR 50 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.
Time frame: at week 12
ACR 70 response at Week 12
ACR 70 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.
Time frame: at week 12
Change in Tender Joint Count at Week 12 as compared to baseline
Change in Tender Joint Count at Week 12 as compared to baseline, with a maximum possible range between -68 to 68 with higher values indicating a worsening of the symptoms.
Time frame: at week 12
Change in Swollen Joint Count at Week 12 as compared to baseline
Change in Swollen Joint Count at Week 12 as compared to baseline, with a maximum possible range between -66 to 66 with higher values indicating a worsening of the symptoms.
Time frame: at week 12
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 as compared to baseline
HAQ-DI score as compared to baseline with a maximum possible range between -3 and 3 with higher values indicating a worsening of the symptoms.
Time frame: at week 12
Psoriasis Area and Severity Index (PASI)75 response at Week 12, assessed in patients with a ≥ 3% baseline Psoriasis (PsO) Body Surface Area (BSA)
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PASI75 is a binary outcome (Yes, No) with 'Yes' indicating improvements of the symptoms.
Time frame: at week 12
Adverse Events
Time frame: up to 14 weeks
Treatment Emergent Adverse Events
Time frame: up to 14 weeks
Serious Adverse Events
Time frame: up to 14 weeks
Intensity of Adverse Events
Intensity of adverse events will be assessed by Rheumatology Common Toxicity Criteria (RCTC) version 2.0. The RCTC criteria consist of 4 grades (1 = mild to 4 = life-threatening) with higher grades indicating a worsening of the symptoms.
Time frame: up to 14 weeks