E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
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E.1.1.1 | Medical condition in easily understood language |
Active Psoriatic Arthritis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective is to compare efficacy of BI 655066 versus placebo at week 16, based on ACR 20 response. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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 |
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E.4 | Principal exclusion criteria |
- 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: ACR 20 response at Week 16
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1: ACR 50 response at Week 16
2: ACR 70 response at Week 16
3: Change in Tender Joint Count at Week 16 as compared to baseline
4: Change in Swollen Joint Count at Week 16 as compared to baseline
5: Change in HAQ-DI at Week 16 as compared to baseline
6: Change in SF-36 at Week 16 as compared to baseline
7: Change in Dactylitis Count at Week 16 as compared to baseline (in patients with dactylitis at baseline)
8: Change in SPARCC Enthesitis Index at Week 16 as compared to baseline (in patients with enthesitis at baseline)
9: Change in mNAPSI at Week 16 as compared to baseline (in patients with nail psoriasis)
10: PASI 90 response at Week 16 assessed in patients with a >/= 3% baseline psoriasis BSA
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 16 weeks
2: 16 weeks
3: 16 weeks
4: 16 weeks
5: 16 weeks
6: 16 weeks
7: 16 weeks
8: 16 weeks
9: 16 weeks
10: 16 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
Czech Republic |
Finland |
France |
Germany |
Japan |
Netherlands |
Poland |
Spain |
Taiwan |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 21 |