Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

September 28, 2018 updated by: Idera Pharmaceuticals, Inc.

A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Fundacion de Investigacion de Diego
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastoenterstinal Specialist of Georgia, PA
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Med Ctr- Columbus
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Texas
      • Dallas, Texas, United States, 75203
        • The Liver Institute
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCV-positive
  • Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

  • Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
  • Inadequate bone marrow, liver, and renal function
  • Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
  • Other significant medical diseases
  • Known alcohol or drug abuse within the past 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMO-2125 0.04 mg/kg q week
IMO-2125 given weekly at 0.04 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Experimental: IMO-2125 0.08 mg/kg q week
IMO-2125 given weekly at 0.08 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Experimental: IMO-2125 0.16 mg/kg q week
IMO-2125 given weekly at 0.16 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Experimental: IMO-2125 0.32 mg/kg q week
IMO-2125 given weekly at 0.32 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Experimental: IMO-2125 0.48 mg/kg q week
IMO-2125 given weekly at 0.48 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Placebo Comparator: Placebo
Weekly saline placebo
Drug: Saline placebo
saline placebo given subcutaneously
Experimental: IMO-2125 0.16 mg/kg twice a week
IMO-2125 given twice a week at 0.16 mg/kg
Drug: IMO-2125
IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Safety.
Time Frame: From screening through study completion, 86 to 115 days in total
Count and percentage of subjects with treatment emergent adverse events
From screening through study completion, 86 to 115 days in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idera Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMO-2125-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on IMO-2125

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe