Rheumatoid arthritis
Conditions
Interventions
Product Code: BI 655064
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655064
Current Sponsor code: BI 655064
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Boehringer Ingelheim España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 (HVs): 1. Healthy males and females according to the investigator?s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2. Age >= 18 and = 18.5 and = 18 and =15mg. 5. Moderate or highly active disease defined as DAS28 4v-CRP >= 3.5 with >= 6 tender and >= 6 swollen joints at screening and confirmed by >= 6 tender and >= 6 swollen joints only at randomisation visit (Visit 2) 6. Serum CRP level >= 1.0 mg/dL at screening 7. Anti-CCP2 positivity as per the limits of used assay 8. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation 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 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Part 1 (HVs): 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator 2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 3. Any evidence of a concomitant disease judged clinically relevant by the investigator 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 5. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders 6. History of relevant orthostatic hypotension, fainting spells, or blackouts 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients) 9. Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication 10. Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial 11. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication 12. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day) 13. Alcohol abuse (consumption of more than 140 g/week in females and 210 g/week in males) 14. Drug abuse or positive drug screen 15. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial) 16. Intention to commence new exercise regimen within one week prior to administration of trial medication or during the trial 17. Inability to comply with dietary regimen of trial site 18. Subject is assessed by the investigator as unsuitable for inclusion e.g. considered not able to understand and comply with study requirements or has a condition that would not allow safe participation in the study 19. Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical TB and/or a positive QuantiFERON TB-Gold test) For female subjects: 20. Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion 21. Lactation Part 2 (RA patients): Part 1 exclusion criteria 19 ? 21 plus: 1. Current or previous use of an approved biologic agent (either anti-TNF or with other mechanism of action, e.g. anakinra, abatacept, tocilizumab or rituximab) or new oral compound (e.g. JAK inhibitors, PTK inhibitors or CXC blockers) for treating RA 2. Current or previous participation in a clinical trial testing an investigational drug for RA 3. DAS28 < 3.2 in at least 2 occasions during the last 6 months before screening Note: DAS28 results during the last 6 months before screening visit will be provided as source documents if available. However, patients with less than 2 DAS28 results available during this time will not be excluded. 4. RA patients with severe disability (functional class IV) or with confirmed severe systemic manifestations e.g. known amyloidosis, Felty´s syndrome, lymphoproliferative disorders, rheumatoid vasculitis 5. Treatment with any standard DMARD except MTX (including but not limited to sulfasalazine, leflunomide, hydroxychloroquine, D-penicillamine, azathioprine, cyclosporin, gold salts) continuing after randomisation Note: If patient is on treatment with any other standard DMARD (except MTX)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and the systemic and local tolerability of repeated doses of BI 655064 (120 mg/mL in buffer solution for injection), administered s.c. at doses of 80, 120 and 180 mg every week in healthy volunteers (HVs) (treatment duration 4 weeks per dose group) and 120 and 180 mg every week in rheumatoid arthritis (RA) patients with prior inadequate response to methotrexate (MTX) therapy (treatment duration 12 weeks per dose group).;Secondary Objective: 1. To evaluate PK and PD parameters of BI 655064 administered in repeated doses in HVs and in RA patients 2. To evaluate the clinical effect of BI 655064 after 12 weeks of treatment with two different doses (120 and 180mg s.c. ew) in RA patients with prior inadequate response to MTX ? establishing the proof of concept in RA.;Primary end point(s): There are no primary safety, PK, PD endpoints in a statistical sense in this study. Primary Endpoint(s) of efficacy - Part 2: - ACR20 response rate;Timepoint(s) of evaluation of this end point: At Week12 (Day 85) from the initiation of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ACR50 and 70 response rates - EULAR Response Criteria (DAS28 4v-CRP) - Percentage of patients with a decrease in DAS28 4v-CRP of >1.2;Timepoint(s) of evaluation of this end point: - At Week12 (Day 85) - At Week12 (Day 85) - At Week 12 (Day 85) compared to baseline | — |
Countries
Australia, Czech Republic, Germany, Netherlands, New Zealand, Spain
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed