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

NCT03943550 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: WP401612017-004599-74
• Study Type: interventional
• Target: 45
• Locations: 5 countries
• Sites: 6

Brief Summary

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. Severity of AEs were graded according to NCI CTCAE v4.0.

  From baseline up to safety follow-up visit on Day 99

Secondary Outcomes (14)

• Time to Maximum Concentration (Tmax) of RO7049665

  Day 1 to Day 15 (predose) and Day 43 (post-dose)

• Maximum Serum Concentration Observed (Cmax) of RO7049665

  Days 1 and 43: Pre-dose, 6 h and 12 h post-dose

• Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUCinf) of RO7049665

  Days 1 and 43: Pre-dose, 6 h and 12 h post-dose

• Change From Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES)

  Baseline, Days 29 and 57

• Change From Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

  Baseline, Days 29 and 57

Study Arms (2)

RO7049665

EXPERIMENTAL

Participants will receive a subcutaneous (SC) dose of RO7049665 every 2 weeks for 4 doses.

Drug: RO7049665

Placebo

PLACEBO COMPARATOR

Participants will receive a SC dose of matching placebo every 2 weeks for 4 doses.

Drug: Placebo

Interventions

RO7049665 DRUG

Multiple ascending doses of RO7049665 will be administered SC.

RO7049665

Placebo DRUG

Matching placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

The Research Institute of Clinical Medicine

Tbilisi, 112, Georgia

Location

Drug Research Centre Gyogyszervizsgalo Kozpontot Kft.

Balatonfüred, 8230, Hungary

Location

SE ÁOK I. sz. Belgyógyászati Klinika

Budapest, 1083, Hungary

Location

ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location

Chisinau, MD-2025, Moldova

Location

Medical center of Yuriy Spizhenko LLC

Kapitanovka Village, KIEV Governorate, 08112, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 13, 2019
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

UA (1); MO (1); GE (1); US (1); HU (2)