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

Primary Purpose

Ulcerative Colitis

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RO7049665

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jacksonville Center for Clinical Research
The Research Institute of Clinical Medicine
Drug Research Centre Gyogyszervizsgalo Kozpontot Kft.
SE ÁOK I. sz. Belgyógyászati Klinika
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Medical Center "Adonis" LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RO7049665

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events

Secondary Outcome Measures

Time to Maximum Concentration (Tmax) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum and the time from SC injection to maximum concentration of RO7049665 will be determined.

Maximum Serum Concentration Observed (Cmax) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum and the maximum concentration of RO7049665 will be determined.

AUC from Time 0 to infinity (AUCinf) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. AUC from time of drug administration extrapolated to infinity (AUCinf) will be determined in a plot of RO7049665 serum concentration versus time.

AUC from Time 0 to Time tau (AUC0-t) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. AUC from time of drug administration to time tau (AUC0-t), which is defined as the time of last measurable serum concentration, will be determined in a plot of RO7049665 serum concentration versus time.

Apparent Clearance (CL/F) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. Clearance, which is a measure of the rate at which a drug is metabolized or eliminated, will be determined.

Apparent Volume of Distribution (V/F) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. Volume of distribution of RO7049665 will be determined.

Half-life (t1/2) of RO7049665

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. t1/2 is the time required for the serum concentration of RO7049665 to be reduced to half.

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

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

Change from Baseline in Histology Score of Sigmoid Colon Biopsies

Change from Baseline in the Mayo Clinic Score (MCS)

Percentage of Participants with Anti-Drug Antibodies

Anti-drug antibody assays will be used to detect anti-drug antibodies against RO7049665. Samples which are positive for anti-drug antibodies will be further assessed using a neutralizing antibody assay.

Change from Baseline in White Blood Cells

Full Information

NCT ID

NCT03943550

First Posted

May 7, 2019

Last Updated

November 22, 2021

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03943550

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

The decision to terminate study WP40161 is based on the lack of robust clinical improvement in the underlying condition after 8 weeks of treatment with RO7049665.

Study Start Date

May 14, 2019 (Actual)

Primary Completion Date

July 22, 2021 (Actual)

Study Completion Date

July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RO7049665

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

RO7049665

Intervention Description

Multiple ascending doses of RO7049665 will be administered SC.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo will be administered SC.

Primary Outcome Measure Information:

Title

Percentage of Participants with Adverse Events

Time Frame

From baseline up to Day 99

Secondary Outcome Measure Information:

Title

Time to Maximum Concentration (Tmax) of RO7049665

Description

Time Frame

From Day 1 to Day 99

Title

Maximum Serum Concentration Observed (Cmax) of RO7049665

Description

Time Frame

From Day 1 to Day 99

Title

AUC from Time 0 to infinity (AUCinf) of RO7049665

Description

Time Frame

From Day 1 to Day 99

Title

AUC from Time 0 to Time tau (AUC0-t) of RO7049665

Description

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. AUC from time of drug administration to time tau (AUC0-t), which is defined as the time of last measurable serum concentration, will be determined in a plot of RO7049665 serum concentration versus time.

Time Frame

From Day 1 to Day 99

Title

Apparent Clearance (CL/F) of RO7049665

Description

Time Frame

From Day 1 to Day 99

Title

Apparent Volume of Distribution (V/F) of RO7049665

Description

Blood samples will be taken pre-dose and at multiple time points after dose administration. RO7049665 concentration will be analyzed in serum. Volume of distribution of RO7049665 will be determined.

Time Frame

From Day 1 to Day 99

Title

Half-life (t1/2) of RO7049665

Description

Time Frame

From Day 1 to Day 99

Title

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

Time Frame

Day 29 and 57

Title

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

Time Frame

Day 29 and 57

Title

Change from Baseline in Histology Score of Sigmoid Colon Biopsies

Time Frame

Day 29 and 57

Title

Change from Baseline in the Mayo Clinic Score (MCS)

Time Frame

Day 29 and 57

Title

Percentage of Participants with Anti-Drug Antibodies

Description

Time Frame

From Day -1 to Day 99

Title

Change from Baseline in White Blood Cells

Time Frame

Pre-dose and Post-dose from Day 1 to Day 71

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

The Research Institute of Clinical Medicine

City

Tbilisi

ZIP/Postal Code

112

Country

Georgia

Facility Name

Drug Research Centre Gyogyszervizsgalo Kozpontot Kft.

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

SE ÁOK I. sz. Belgyógyászati Klinika

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location

City

Chisinau

ZIP/Postal Code

MD-2025

Country

Moldova, Republic of

Facility Name

Medical Center "Adonis" LLC

City

Kapitanovka Village

State/Province

KIEV Governorate

ZIP/Postal Code

08112

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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