Status:
COMPLETED
Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 (ph...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05332704
Start Date
March 25 2022
End Date
July 18 2024
Last Update
August 21 2024
Active Locations (4)
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1
Arensia Exploratory Medicine Phase 1 Unit
Chisinau, Moldova, MD-2025
2
Arensia Exploratory Medicine
Bucharest, Romania, 011658
3
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW
4
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ