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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05332704
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ono Pharmaceutical Co. Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Project Leader
Principal Investigator Affiliation Ono Pharmaceutical Co. Ltd
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Moldova, Republic of, Romania, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Plaque Psoriasis
Arms & Interventions

Arms

Experimental: Part A, Active

Placebo Comparator: Part A, Placebo

Experimental: Part B, Active

Placebo Comparator: Part B, Placebo

Experimental: Part C, Active

Placebo Comparator: Part C, Placebo

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chisinau, Moldova, Republic of

Status

Recruiting

Address

Arensia Exploratory Medicine Phase 1 Unit

Chisinau, , MD-2025

Site Contact

Lilia Taran

trials.uk-eu@ono-pharma.com

Arensia Exploratory Medicine, Bucharest, Romania

Status

Recruiting

Address

Arensia Exploratory Medicine

Bucharest, , 011658

Site Contact

Olguta Orzan

trials.uk-eu@ono-pharma.com

Hammersmith Medicines Research, London, United Kingdom

Status

Recruiting

Address

Hammersmith Medicines Research

London, , NW10 7EW

Site Contact

Adeep Puri

trials.uk-eu@ono-pharma.com

Medicines Evaluation Unit, Manchester, United Kingdom

Status

Recruiting

Address

Medicines Evaluation Unit

Manchester, , M23 9QZ

Site Contact

Naimat Khan

trials.uk-eu@ono-pharma.com

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