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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-07-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a phase I, multi-centre study to assess the safety, tolerability, PK \& PD of ONO-4685. This study consists of: Part A single ascending dose, Part B an assessment of multiple doses \& Part C to undertake initial assessment of efficacy with multiple doses.

The study will recruit patients, male \& female, with mild or moderate psoriasis diagnosed for at least 6 months. Following screening activities, patients are admitted to a clinical unit 1 day ahead of dosing and will stay at the unit for 4 nights. For patients receiving multiple doses, they will attend the clinic on the day of dosing and will stay for 3 nights. All patients will be followed up, for up to 24 weeks from 1st dose.

The study will recruit 6 patients per cohort for part A \& B and 18 patients per cohort for part C. The overall active to placebo ratio will be 2:1.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blind study.

The pharmacist will be unblinded and is responsible for preparing blinded drug for administration.

Study Groups

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Part A, Active

Group Type EXPERIMENTAL

ONO-4685

Intervention Type DRUG

-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5).

Part A, Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).

Part B, Active

Group Type EXPERIMENTAL

ONO-4685

Intervention Type DRUG

-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2)

Part B, Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).

Part C, Active

Group Type EXPERIMENTAL

ONO-4685

Intervention Type DRUG

-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2).

Part C, Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).

Interventions

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ONO-4685

-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5).

Intervention Type DRUG

Placebo

-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).

Intervention Type DRUG

ONO-4685

-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2)

Intervention Type DRUG

Placebo

-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).

Intervention Type DRUG

ONO-4685

-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2).

Intervention Type DRUG

Placebo

-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be willing and able to participate in the study
* A diagnosis of plaque-type psoriasis for ≥6 months.
* Plaque-type psoriasis involving ≥3% of body surface area (BSA) (Parts B and C).
* Willing to provide skin biopsies (Parts B and C).
* Subjects in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests.
* Subjects willing to comply with the contraception and sperm and ova donation requirements of the protocol.

Exclusion Criteria

* Subjects with any clinically significant abnormality in screening tests.
* Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the psoriasis, or other skin condition (eg eczema).
* Presence or history of alcohol or drugs abuse.
* Heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day).
* Subjects have had any 'live' vaccines (excluding COVID-19 vaccine) during the 3 months before the first dose of study medicine.
* Subjects have had a first COVID-19 vaccine within 6 weeks or second and booster COVID-19 vaccinations within 2 weeks before the first dose of study medicine.
* Subjects have had any clinically significant disease or infection, including tuberculosis.
* Presence or history of malignancy (cancer) including lymphoproliferative disorders.
* Subject is pregnant, lactating, or breastfeeding.
* Subjects have received treatment with biologics in the last 3 months, immunosuppressant medicine or prescription medicine for psoriasis within 4 weeks before admission to the ward; have used phototherapy from 2 weeks before admission to the ward; have used highly potent or potent topical steroids within 2 weeks before admission to the ward.
* Subjects have used topical corticosteroids or Vitamin D analogues within 7 days before admission to the ward (Parts B and C).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No