Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 December 2021
• Main ID: NCT03943550
• Date of registration: 07/05/2019
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis
• Date of first enrolment: May 14, 2019
• Target sample size: 45
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03943550
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Georgia, Hungary, Moldova, Republic of, Ukraine, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with Ulcerative Colitis (UC) for at least 12 weeks prior to screening

- Screening colonoscopy for colorectal cancer conducted within the prior two years if a
history of pancolitis with disease duration = 8 years or history of left-sided colitis
and disease duration =12 years

- Evidence of disease activity at time of screening

- Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC

Exclusion Criteria:

- Diagnosis of Crohn's disease or indeterminate colitis

- History of infection with hepatitis B, human immunodeficiency virus (HIV), active
hepatitis C virus (HCV) infection, or other chronic infection

- Active infections requiring systemic therapy with antibiotic, antiviral or antifungal
or febrile illness within 7 days before Day -1

- History of primary or acquired immunodeficiency

- Abnormal hematologic values

- Abnormal hepatic enzyme or hepatic function values



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: RO7049665

Drug: Placebo

Primary Outcome(s)

Percentage of Participants with Adverse Events [Time Frame: From baseline up to Day 99]

Secondary Outcome(s)

Change from Baseline in Histology Score of Sigmoid Colon Biopsies [Time Frame: Day 29 and 57]

Time to Maximum Concentration (Tmax) of RO7049665 [Time Frame: From Day 1 to Day 99]

AUC from Time 0 to Time tau (AUC0-t) of RO7049665 [Time Frame: From Day 1 to Day 99]

Change from Baseline in the Mayo Clinic Score (MCS) [Time Frame: Day 29 and 57]

Apparent Volume of Distribution (V/F) of RO7049665 [Time Frame: From Day 1 to Day 99]

AUC from Time 0 to infinity (AUCinf) of RO7049665 [Time Frame: From Day 1 to Day 99]

Change from Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES) [Time Frame: Day 29 and 57]

Half-life (t1/2) of RO7049665 [Time Frame: From Day 1 to Day 99]

Apparent Clearance (CL/F) of RO7049665 [Time Frame: From Day 1 to Day 99]

Change from Baseline in White Blood Cells [Time Frame: Pre-dose and Post-dose from Day 1 to Day 71]

Change from Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) [Time Frame: Day 29 and 57]

Percentage of Participants with Anti-Drug Antibodies [Time Frame: From Day -1 to Day 99]

Maximum Serum Concentration Observed (Cmax) of RO7049665 [Time Frame: From Day 1 to Day 99]

Secondary ID(s)

WP40161

2017-004599-74

Source(s) of Monetary Support

Please refer to primary and secondary sponsors