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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: IMO-2125; Drug: Saline placebo

• Registration Number: NCT00728936
• Lead Sponsor: Idera Pharmaceuticals, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2017-11
• Results First Submitted: 2017-11-28
• Results First Submitted QC: 2018-09-28
• Last Update Submitted: 2018-09-28
• Results First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMO-2125 0.16 mg/kg q week	IMO-2125	IMO-2125 given weekly at 0.16 mg/kg
IMO-2125 0.08 mg/kg q week	IMO-2125	IMO-2125 given weekly at 0.08 mg/kg
IMO-2125 0.32 mg/kg q week	IMO-2125	IMO-2125 given weekly at 0.32 mg/kg
IMO-2125 0.48 mg/kg q week	IMO-2125	IMO-2125 given weekly at 0.48 mg/kg
IMO-2125 0.04 mg/kg q week	IMO-2125	IMO-2125 given weekly at 0.04 mg/kg
IMO-2125 0.16 mg/kg twice a week	IMO-2125	IMO-2125 given twice a week at 0.16 mg/kg
Placebo	Saline placebo	Weekly saline placebo

Primary Outcome Measures

Name	Time	Method
Evaluation of Safety.	From screening through study completion, 86 to 115 days in total	Count and percentage of subjects with treatment emergent adverse events

Trial Locations

Locations (7)

Henry Ford Med Ctr- Columbus; 🇺🇸 Novi, Michigan, United States

Fundacion de Investigacion de Diego; 🇵🇷 Santurce, Puerto Rico

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Gastoenterstinal Specialist of Georgia, PA; 🇺🇸 Marietta, Georgia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States

The Liver Institute; 🇺🇸 Dallas, Texas, United States