NCT05332704

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	ONO-4685	-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5).
DRUG	Placebo	-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).
DRUG	ONO-4685	-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2)
DRUG	Placebo	-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).
DRUG	ONO-4685	-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2).
DRUG	Placebo	-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).

Timeline

• Start date: 2022-03-25
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2022-04-18
• Last updated: 2024-08-21

Locations

4 sites across 3 countries: Moldova, Romania, United Kingdom