A study to test different doses of BI 730357 and find out whether they reduce symptoms in people with active psoriatic arthritis

Phase 1

• Conditions: psoriatic arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-003182-17-HU
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-31
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified