Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

NCT01622348 | Completed Phase 2 Results DMC

• 1 other identifier: 3100-202
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to evaluate different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Conditions

Actively Extending Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

Keywords

Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment

  The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Saline for Injection

Drug: Saline for Injection

IMO-3100 at 0.16 mg/kg

ACTIVE COMPARATOR

IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection

Drug: IMO-3100 at 0.16 mg/kg

IMO-3100 at 0.32 mg/kg

ACTIVE COMPARATOR

IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

Drug: IMO-3100 at 0.32 mg/kg

Interventions

IMO-3100 at 0.16 mg/kg DRUG

IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection

IMO-3100 at 0.16 mg/kg

Saline for Injection DRUG

Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL

Placebo

IMO-3100 at 0.32 mg/kg DRUG

IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection

IMO-3100 at 0.32 mg/kg

Eligibility Criteria

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

You may qualify if:

• Is age 18 to 70 years, inclusive;
• Completes the informed consent procedure (see Section 15.3), including signing and dating the informed consent form;
• Has moderate to severe plaque psoriasis meeting the criteria specified above;
• Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment;
• Female subjects of childbearing potential (see Section 8.4.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.4.1) from Screening through the treatment period and for four (4) weeks after the last injection of study drug.

You may not qualify if:

• Has known hypersensitivity to any oligodeoxynucleotide;
• Is nursing;
• Has body weight \< 50 kg;
• Has BMI \> 34.9 kg/m2;
• Regularly consumes \> 3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day;
• Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus;
• Has a positive test for hepatitis B surface antigen (HBsAg);
• Has at screening safety laboratory tests meeting one or more of the following criteria:
• hemoglobin \< 10.5 g/dL
• white blood cell count \< 4,000 cells/mm3
• absolute neutrophil count (ANC) \< 1500/mm3
• platelet count \< 100,000/mm3
• alanine transaminase (ALT; SGPT) \> 1.5x ULN
• aspartate transaminase (AST; SGOT) \> 1.5x ULN
• serum total bilirubin \> 1.4x ULN

Sponsors & Collaborators

• Idera Pharmaceuticals, Inc.: lead

Study Sites (13)

Florida Center for Dermatology, P.A

Jacksonville, Florida, 32204, United States

Location

Atlanta Dermatology, Vein & Research Center, PC

Alpharetta, Georgia, 30022, United States

Location

Dermatologic Surgery Specialists, Inc.

Macon, Georgia, 31217, United States

Location

Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

DermResearch PLLC

Louisville, Kentucky, 40217, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mass General Hospital Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02199, United States

Location

Derm Research Center of New York

Stony Brook, New York, 11790, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Clinical Partners, Inc

Johnston, Rhode Island, 02919, United States

Location

J & S Studies

College Station, Texas, 77845, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

University of Utah, Dermatology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Sodium Chloride; Injections

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Idera Medical Monitor
• Organization: Idera Pharmaceuticals, Inc.

clinicaltrials@iderapharma.com

617-679-5500

Study Officials

• Robert D Arbeit, MD

  Idera Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 9, 2018
• Results First Posted: November 13, 2017

Record last verified: 2017-12

Locations

US (13)