A study to test different doses of BI 730357 and find out the effect they have on symptoms in people with active psoriatic arthritis
A Phase II, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging, efficacy and safety trial of BI 730357 given for 12 weeks in patients with active psoriatic arthritis
Boehringer Ingelheim Pty Ltd
160 participants
Apr 4, 2022
Interventional
Conditions
Summary
This trial is designed to evaluate safety, tolerability, PK and PD of BI 730357 in male and female patients with psoriatic arthritis using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 730357. Although effective treatments for psoriatic arthritis are approved, the unmet medical need remains for safer oral therapy that works well, improves joint and skin inflammation, prevents structural damage and maintains the efficacy over time. This trial is a randomised, double-blind, placebo-controlled trial in which three dose regiments of BI 730357 will be compared to placebo over a 12-week treatment period. Only approximately 40 patients out of total 160 patients will be randomized to receive placebo treatment. A placebo-control design is required for evaluation of evaluation of BI 730357 efficacy and safety. In addition, a placebo arm is needed in order to avoid potential confounding factors, such as placebo effect, potential investigator bias in safety and efficacy assessment or regression to the mean in endpoint scoring. In addition, as a risk mitigation strategy, if the patient experiences an intolerable increase in diseases activity of psoriatic arthritis during the course of the trial treatment, the patient will be discontinued from the trial treatment and will receive a standard of care treatment as deemed appropriate by the investigator.
Eligibility
Inclusion Criteria6
- Males or females, aged >/= 18 years and <= 75 years at screening
- Have PsA symptoms for at least 6 months prior to screening, as assessed by the investigator
- Have PsA on the basis of the CASPAR with peripheral symptoms at screening visit, as assessed by the investigator
- Have at least 3 tender joints and at least 3 swollen joints at screening and randomisation visits, as assessed by the investigator
- At least one PsO skin or nail lesion or a documented personal history of PsO at screening, as assessed by the investigator
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Exclusion Criteria7
- 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
- Active uveitis or uveitis within 4 weeks prior to randomisation disease assessed by the investigator
- Suspected or diagnosed inflammatory bowel disease assessed by the investigator
- Previous exposure to BI 730357
- Prior use of any therapeutic agent directly targeted to IL-12/23, IL-23 or IL-17
- Prior use of more than two different TNFi agents
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Interventions
Randomised, double-blind, placebo-controlled, parallel group, doseranging, of treatment over 12 weeks with three BI 730357 dose levels compared to placebo. 160 patients globally will be randomised in a 1:1:1:1 ratio in the following groups: Arm 1: 100 mg, n=40 Arm 2: 200 mg, n=40 Arm 3: 400 mg, n=40 The doses listed above will be administered in tablet form. Every patient will be required to take 3 tablets, once per day for 12 weeks. The patient's adherence to taking the trial medication will be checked by clinical trial staff at study visits. The patient will be required to complete a diary to document their compliance. Arm 4: matching placebo, n=40
Locations(17)
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ACTRN12620001092987