BI 655066 compared to placebo in patients with active psoriatic arthritis
- Conditions
- Active Psoriatic ArthritisMedDRA version: 18.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-003625-34-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 251
- Have PsA symptoms for >/= 6 months prior to screening, as assessed by the investigator
- Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR) with peripheral symptoms at screening visit, as assessed by the investigator
- Have >/= 5 tender joints and >/= 5 swollen joints at screening and randomisation visits, as assessed by the investigator
- At least one PsO lesion or a documented personal history of PsO at screening, as assessed by the investigator
- If patients receive concurrent PsA treatments, these need to be on stable doses
- Active PsA that has been inadequately controlled by standard doses of NSAIDs administered for >/= 4 weeks, or traditional DMARDs (including sulfasalazine) administered for >/= 3 months, or TNFi agents, or subjects are intolerant to NSAIDs or DMARDs or TNFi agents, as assessed by the investigator
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Further inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Major chronic inflammatory or connective tissue disease other than PsA (e.g. rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme disease, gout) and fibromyalgia, as assessed by the investigator
- Has received any therapeutic agent directly targeted to IL-12/23 (including ustekinumab), IL-23 or IL-17 (including secukinumab)
- Prior use of more than two different TNFi agents
- Use of the following treatments: TNFi agents within 12 weeks, etanercept within 8 weeks, leflunomide without cholestyramine wash-out within 8 weeks, systemic non-biologic medications for psoriatic arthritis or psoriasis and photochemotherapy within 4 weeks, intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks, topical psoriasis medications and phototherapy within 2 weeks, low and high potency opioid analgesics within 2 weeks prior to randomisation
- Plans for administration of live vaccines during the study period or within 6 weeks prior to randomisation
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Active systemic infections during the last 2 weeks (exception: common cold) prior to randomisation, as assessed by the investigator
- Chronic or relevant acute infections including HIV, viral hepatitis and (or) active tuberculosis. Patients with a positive QuantiFERON TB or PPD test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then tuberculosis treatment may be deferred until completion of the trial according to clinical judgment of investigator and local country guidelines.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Major surgery performed within 12 weeks prior to randomisation or planned within 32 weeks after randomisation (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
- Total white blood count (WBC) < 3,000/µL, or platelets < 100,000/µL or neutrophils < 1,500/µL, or hemoglobin <8.5 g/dL at screening
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x the upper limit of normal, or serum direct bilirubin = 1.5 mg/dL at screening
- Positive rheumatoid factor or anti-cyclic-citrullinated peptide (anti-CCP) antibodies at screening
- Further exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is to compare efficacy of BI 655066 versus placebo at week 16, based on ACR 20 response.;Secondary Objective: To compare efficacy of BI 655066 versus placebo at week 16, based on ACR 50 response, ACR 70 response, change in tender joint count and swollen joint count, HAQ-DI, SF-36, dactylitis count, SPARCC enthesitis index, mNAPSI and PASI 90 (only in patients with >/= 3% baseline psoriasis BSA).;Primary end point(s): 1: ACR 20 response at Week 16;Timepoint(s) of evaluation of this end point: 1: 16 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1: 16 weeks<br><br>2: 16 weeks<br><br>3: 16 weeks<br><br>4: 16 weeks<br><br>5: 16 weeks<br><br>6: 16 weeks<br><br>7: 16 weeks<br><br>8: 16 weeks<br><br>9: 16 weeks<br><br>10: 16 weeks;Secondary end point(s): 1: ACR 50 response at Week 16<br><br>2: ACR 70 response at Week 16<br><br>3: Change in Tender Joint Count at Week 16 as compared to baseline<br><br>4: Change in Swollen Joint Count at Week 16 as compared to baseline<br><br>5: Change in HAQ-DI at Week 16 as compared to baseline<br><br>6: Change in SF-36 at Week 16 as compared to baseline<br><br>7: Change in Dactylitis Count at Week 16 as compared to baseline (in patients with dactylitis at baseline)<br><br>8: Change in SPARCC Enthesitis Index at Week 16 as compared to baseline (in patients with enthesitis at baseline)<br><br>9: Change in mNAPSI at Week 16 as compared to baseline (in patients with nail psoriasis)<br><br>10: PASI 90 response at Week 16 assessed in patients with a >/= 3% baseline psoriasis BSA