A Phase I Study of RO7021610 in Patients with Ulcerative Colitis

A Phase I Multiple-Dose Study of RO7021610 in Japanese Patients with Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224649

Enrollment

Registered

2019-04-17

Start date

2019-06-01

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

Ulcerative colitis

Interventions

investigational material(s) Generic name etc : RO7021610 INN of investigational material : Efmarodocokin alfa Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Japanese patients with ulcerative colitis - Diagnosis of ulcerative colitis established and confirmed at least 3 months prior to screening initiation - Diagnosis of moderate-to-severe ulcerative colitis (Mayo endoscopic subscore >=2) - Inadequate response, loss of response, or intolerance to prior treatment for moderate to severe ulcerative colitis

Exclusion criteria

Exclusion criteria: - Confirmed or suspected diagnosis of colitis other than ulcerative colitis - Diagnosis of ulcerative proctitis - Prior and planned surgery for ulcerative colitis - History of malignancy

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics Safety and PK	—

Secondary

Measure	Time frame
other anti-drug antibody	—

Countries

Japan

Outcome results

None listed

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