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Completed

NCT Number: NCT05332704

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

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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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine Phase 1 Unit, Chisinau, Moldova

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ONO-4685

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Treatment emergent adverse events (TEAEs) by severity

    Time frame: End of Study (3 years)

    Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receives study drug without regard to possible causal relationship.

  2. Clinical laboratory tests

    Time frame: End of Study (3 years)

    Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).

  3. Cytokines

    Time frame: Up to day 8 post dosing day

    Number of participants with elevated cytokines.

  4. Lymphocytes

    Time frame: End of Study (3 years)

    Number of participants with depleted lymphocytes.

  5. Vital signs (blood pressure)

    Time frame: End of Study (3 years)

    Number of participants with clinically significant changes in vital signs (blood pressure)

  6. Vital signs (respiration rate)

    Time frame: End of Study (3 years)

    Number of participants with clinically significant changes in vital signs (respiration rate)

  7. Vital signs (temperature)

    Time frame: End of Study (3 years)

    Number of participants with clinically significant changes in vital signs (temperature)

  8. Vital signs (pulse rate)

    Time frame: End of Study (3 years)

    Number of participants with clinically significant changes in vital signs (pulse rate)

  9. ECG parameters

    Time frame: End of Study (3 years)

    Number of participants with ECG abnormalities.

Secondary outcomes

  1. Pharmacokinetics (Ceoi)

    Time frame: Part A, Day 1 (day of dosing). Part B and C, Day 1 (day of first dose) and Day 15 or 22 (day of last dose) depending on weekly or bi-weekly dosing.

    Assessment of the observed plasma concentration of ONO-4685 at the end of infusion (eoi).

  2. Pharmacokinetics, Cmax

    Time frame: Part A up to day 85, Part B and Part C up to day 113

    Assessment of the maximum observed plasma concentration of ONO-4685.

  3. Pharmacokinetics, Tmax

    Time frame: Part A up to day 85, Part B and Part C up to day 113

    Assessment of the time of maximum plasma concentration of ONO-4685.

  4. Pharmacokinetics, AUC last

    Time frame: Part A up to day 85

    Assessment of the area under the plasma ONO-4685 concentration-time curve from time 0 to time of the last quantifiable concentration.

  5. Pharmacokinetics, AUCinf

    Time frame: Part A up to day 85

    Assessment of the area under the plasma ONO-4685 concentration-time curve from time 0 to infinity.

  6. Pharmacokinetics, CL (Clearance)

    Time frame: Part A up to day 85

    Assessment of the plasma clearance of ONO-4685.

  7. Pharmacokinetics, Vss

    Time frame: Part A up to day 85

    Assessment of the volume of distribution at steady state of ONO-4685

  8. Pharmacokinetics, T1/2

    Time frame: Part A up to day 85, and after the last dose administration (Day 15 or 22) in Part B and Part C up to day 113.

    Assessment of the terminal elimination half-life of ONO-4685 in plasma.

  9. Pharmacokinetics, AUCtau

    Time frame: Part B and C, after first (Day 1) and last (Day 15 or 22) dose

    Assessment of the area under the plasma ONO-4685 concentration-time curve during the dosing interval.

  10. Pharmacokinetics, Ctrough

    Time frame: Part B and C, prior to administration of each dose

    Assessment of the trough concentration of ONO-4685 in plasma.

  11. Pharmacodynamics, lymphocytes

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of total lymphocytes, including subsets CD4+ T cell, CD8+ T cell, B cell and NK cell.

  12. Pharmacodynamics, immunoglobulin

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of total immunoglobulin, IgA, IgG and IgM.

  13. Pharmacodynamics, cytokines

    Time frame: Part A up to day 8, Part B and Part C up to day 8 post last dose

    Assessment of cytokines, including IL-2, IL-6, IL-10, TNF-α and INF-γ.

  14. Immunogenicity, Anti-ONO-4685-antibodies (ADA)

    Time frame: Part A up to day 85, Part B and Part C up to day 113

    Assessment of antibodies generated to ONO-4685 to measure potential immunogenicity.

  15. Efficacy, Psoriasis Area and Severity Index (PASI)

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of change in PASI from baseline.

  16. Efficacy, Psoriasis Area and Severity Index (PASI) 50

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of number of subjects that achieve PASI 50, a 50% reduction in PASI from baseline.

  17. Efficacy, Psoriasis Area and Severity Index (PASI) 75

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of number of subjects that achieve PASI 75, a 75% reduction in PASI from baseline.

  18. Efficacy, Psoriasis Area and Severity Index (PASI) 90

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of number of subjects that achieve PASI 90, a 90% reduction in PASI from baseline.

  19. Efficacy, Target Plaque Severity Score (TPSS)

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of change in TPSS from baseline.

  20. Efficacy, Physician's Global Assessment (PGA)

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of change in PGA from baseline.

  21. Efficacy, Physician's Global Assessment (PGA) 0/1

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of the number of subjects that achieve PGA 0/1.

  22. Efficacy, Physician's Global Assessment (PGA) 0/1 and a 2-point improvement

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of the number of subjects that achieve PGA 0/1 and a 2-point improvement from baseline.

  23. Efficacy, Body Surface Area (BSA)

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of the change in plaque BSA from baseline

  24. Patient Reported Outcome, Dermatology Life Quality Index (DLQI)

    Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169

    Assessment of the change in DLQI from baseline.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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