psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: BI 730357
Product Code: BI 730357
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BI 730357
Other descriptive name: BI 730357
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and = 75 years at screening, males or females 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Have PsA symptoms for = 6 months prior to screening, as assessed by the investigator 4. Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR) with peripheral symptoms at screening visit, as assessed by the investigator 5. Have = 3 tender joints and = 3 swollen joints at screening and randomisation visits, as assessed by the investigator 6. At least one PsO skin or nail lesion or a documented personal history of PsO at screening, as assessed by the investigator 7. If patients receive concurrent PsA treatments, these need to be on stable doses as below: - For patients receiving MTX: patient has received treatment for = 3 months, with stable dose and stable route of administration (not to exceed 20 mg MTX per week) for = 4 weeks prior to randomisation to EOO; patients on MTX should be taking folic acid supplementation according to local standard of care before randomisation and during the trial to minimize the likelihood of MTX associated toxicity - For patients receiving oral corticosteroids: the patient must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for = 2 weeks prior to randomisation to EOO, - For patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol/acetaminophen PRN: the patient must be on stable dose for = 2 weeks prior to randomisation to EOO 8. Women of child-bearing potential (WoCBP)** must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the study and the patient must agree to periodic pregnancy testing during participation in the trial. There are no specific contraceptive requirements for male participants. Patients (males or females) following the national regulatory guidelines regarding contraception if receiving MTX as background therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Major chronic inflammatory or connective tissue disease other than PsA (e.g. rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator 2. Active uveitis or uveitis within 4 weeks prior to randomisation, assessed by the investigator 3. Suspected or diagnosed inflammatory bowel disease, assessed by the investigator 4. Previous exposure to BI 730357 5. Prior use of any therapeutic agent directly targeted to IL-12/23, IL-23 or IL-17 6. Prior use of more than two different TNFi agents 7. Use of the following treatments: - TNFi agents (including, infliximab, adalimumab, certolizumab pegol or golimumab) within 8 weeks prior to randomisation - Etanercept within 4 weeks prior to randomisation - Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation - Systemic non-biologic medications for PsA or PsO (including traditional DMARDs, apremilast, a JAK inhibitor or leflunomide with cholestyramine wash-out) or photochemotherapy within 4 weeks prior to randomisation - Intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks prior to randomisation - Topical PsO medications and phototherapy within 2 weeks prior to randomisation, - Low and high potency opioid analgesics (e.g. tramadol, methadone, hydromorphone, morphine) within 2 weeks prior to randomisation 8. Live vaccination = 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this study. BCG vaccination is restricted 1 year prior to randomisation through EOO visit. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess efficacy, safety and tolerability of BI 730357 in treatment of patients with active PsA. ;Secondary Objective: Clinical efficacy (based on secondary endpoints) will be evaluated. Safety of BI 730357 will be evaluated during treatment and follow-up period.;Primary end point(s): 1) ACR 20 response;Timepoint(s) of evaluation of this end point: 1) Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) ACR 50 response at Week 12 2) ACR 70 response at Week 12 3) Change in Tender Joint Count at Week 12 as compared to baseline 4) Change in Swollen Joint Count at Week 12 as compared to baseline 5) Change in HAQ-DI at Week 12 as compared to baseline 6) PASI75 response at Week12, assessed in patients with a = 3% baseline PsO BSA 7) AEs 8) Treatment emergent AEs 9) SAEs 10) Intensity (assessed on RCTC criteria) 11) Safety Laboratory Values (haematology, clinical chemistry and urinanalysis) - Vital Signs;Timepoint(s) of evaluation of this end point: 1) through 7): 12 Weeks 8) through 12): up to 14 Weeks | — |
Countries
Australia, Belgium, Bulgaria, Czech Republic, Georgia, Germany, Hungary, Japan, Luxembourg, Mexico, Moldova, Republic of, New Zealand, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim RCV GmbH & Co KG
Outcome results
None listed