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ONO-4059-08:ONO-4059 phase 1

ONO-4059-08:ONO-4059 Phase I Study An Open-label, Randomized, Parallel-group Comparative Study in Patients with Systemic Sclerosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031200315
Enrollment
16
Registered
2021-01-20
Start date
2021-03-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Interventions

Sponsors

Terasawa Tetsuji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Either inpatient or outpatient 2.Patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Systemic Sclerosis 3.Patients with progressive systemic sclerosis with moderate or severe skin thickness

Exclusion criteria

Exclusion criteria: 1.Patients with serious complications associated with systemic sclerosis other than interstitial lung disease 2.Patients with severe chronic lung disease 3.Patients with serious and uncontrollable organ dysfunction not associated with systemic sclerosis 4.Patients with a disease other than systemic sclerosis that necessitates systemic corticosteroid administration within 12 weeks before the start of the observation period 5.Patients with an active infection

Design outcomes

Primary

MeasureTime frame
Adverse events, Pharmacokinetics, Efficacy(Exploratory objective)

Contacts

Public ContactMedical Center

Ono Pharmaceutical Co.,LTD

clinical_trial@ono.co.jp+81-120-626-190

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026