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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943550
Recruitment Status : Terminated (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.)
First Posted : May 9, 2019
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RO7049665 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 14, 2019
Actual Primary Completion Date : July 22, 2021
Actual Study Completion Date : July 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RO7049665
Participants will receive a subcutaneous (SC) dose of RO7049665 every 2 weeks for 4 doses.
 Drug: RO7049665
Multiple ascending doses of RO7049665 will be administered SC.
Placebo Comparator: Placebo
Participants will receive a SC dose of matching placebo every 2 weeks for 4 doses.
 Drug: Placebo
Matching placebo will be administered SC.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: From baseline up to Day 99 ]

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

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

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

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

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

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

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

  8. Change from Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES) [ Time Frame: Day 29 and 57 ]
  9. Change from Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) [ Time Frame: Day 29 and 57 ]
  10. Change from Baseline in Histology Score of Sigmoid Colon Biopsies [ Time Frame: Day 29 and 57 ]
  11. Change from Baseline in the Mayo Clinic Score (MCS) [ Time Frame: Day 29 and 57 ]
  12. Percentage of Participants with Anti-Drug Antibodies [ Time Frame: From Day -1 to Day 99 ]
    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.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943550


Locations
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United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Georgia
The Research Institute of Clinical Medicine
Tbilisi, Georgia, 112
Hungary
Drug Research Centre Gyogyszervizsgalo Kozpontot Kft.
Balatonfüred, Hungary, 8230
SE ÁOK I. sz. Belgyógyászati Klinika
Budapest, Hungary, 1083
Moldova, Republic of
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Chisinau, Moldova, Republic of, MD-2025
Ukraine
Medical Center "Adonis" LLC
Kapitanovka Village, KIEV Governorate, Ukraine, 08112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03943550    
Other Study ID Numbers: WP40161
2017-004599-74 ( EudraCT Number )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases