A Randomised, Multi-centre, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Dose Study to Assess Safety, Tolerability, PK, PD & Preliminary Efficacy of IV Doses of ONO-4685 in Patients With Plaque Psoriasis
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Plaque Psoriasis
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 33
- Locations
- 4
- Primary Endpoint
- Treatment emergent adverse events (TEAEs) by severity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.
The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A, Placebo
Intervention: Placebo
Part A, Active
Intervention: ONO-4685
Part B, Active
Intervention: ONO-4685
Part B, Placebo
Intervention: Placebo
Part C, Active
Intervention: ONO-4685
Part C, Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Treatment emergent adverse events (TEAEs) by severity
Time Frame: End of Study (3 years)
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receives study drug without regard to possible causal relationship.
Clinical laboratory tests
Time Frame: End of Study (3 years)
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).
Cytokines
Time Frame: Up to day 8 post dosing day
Number of participants with elevated cytokines.
Lymphocytes
Time Frame: End of Study (3 years)
Number of participants with depleted lymphocytes.
Vital signs (blood pressure)
Time Frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (blood pressure)
Vital signs (temperature)
Time Frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (temperature)
Vital signs (respiration rate)
Time Frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (respiration rate)
Vital signs (pulse rate)
Time Frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (pulse rate)
ECG parameters
Time Frame: End of Study (3 years)
Number of participants with ECG abnormalities.
Secondary Outcomes
- Pharmacokinetics, AUC last(Part A up to day 85)
- Pharmacokinetics, AUCinf(Part A up to day 85)
- Pharmacokinetics, Cmax(Part A up to day 85, Part B and Part C up to day 113)
- Pharmacokinetics, Tmax(Part A up to day 85, Part B and Part C up to day 113)
- Pharmacokinetics (Ceoi)(Part A, Day 1 (day of dosing). Part B and C, Day 1 (day of first dose) and Day 15 or 22 (day of last dose) depending on weekly or bi-weekly dosing.)
- Pharmacokinetics, CL (Clearance)(Part A up to day 85)
- Pharmacokinetics, T1/2(Part A up to day 85, and after the last dose administration (Day 15 or 22) in Part B and Part C up to day 113.)
- Pharmacokinetics, AUCtau(Part B and C, after first (Day 1) and last (Day 15 or 22) dose)
- Pharmacodynamics, cytokines(Part A up to day 8, Part B and Part C up to day 8 post last dose)
- Immunogenicity, Anti-ONO-4685-antibodies (ADA)(Part A up to day 85, Part B and Part C up to day 113)
- Efficacy, Psoriasis Area and Severity Index (PASI)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 50(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 75(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 90(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Target Plaque Severity Score (TPSS)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA) 0/1(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Pharmacokinetics, Vss(Part A up to day 85)
- Pharmacokinetics, Ctrough(Part B and C, prior to administration of each dose)
- Pharmacodynamics, immunoglobulin(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Patient Reported Outcome, Dermatology Life Quality Index (DLQI)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Pharmacodynamics, lymphocytes(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA) 0/1 and a 2-point improvement(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Body Surface Area (BSA)(Part A up to day 85, Part B up to day 113, Part C up to day 169)