NCT05332704CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 18 Mar 2022
- Start date
- 25 Mar 2022
- Primary completion date
- 18 Jul 2024
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT05332704
- EudraCT number
- 2021-002151-10
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 33
- From 25 Mar 2022 to the primary completion date, 18 Jul 2024
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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).
Other illness
- 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.
- Subjects have had any clinically significant disease or infection, including tuberculosis.
- Presence or history of malignancy (cancer) including lymphoproliferative disorders.
Other
- Subjects with any clinically significant abnormality in screening tests.
- Heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day).
- Subject is pregnant, lactating, or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hammersmith Medicines Research Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Medicines Evaluation Unit Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Arensia Exploratory Medicine Phase 1 Unit Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.