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Trial record 24 of 762 for:    plaque | "Psoriasis"

A 12-week Dose-Ranging Trial in Patients With Moderate to Sever Plaque Psoriasis (8400-201)

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ClinicalTrials.gov Identifier: NCT01899729
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Brief Summary:

IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be encountered during infection) and endogenous nucleic acids (as might be released during tissue damage during autoimmune disease). In vitro and in multiple animal models of autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were well-tolerated, with mild injection site reactions and no pattern of systemic reactions or laboratory changes.

The current study represents the first clinical trial of IMO-8400 in patients with active autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist which demonstrated clinical improvement in this patient population.


Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: IMO-8400 Drug: Saline Placebo Phase 2

Detailed Description:
Eligible subjects will be enrolled and randomized to receive one of the four treatments (three dose levels of IMO-8400 or Saline Placebo). Treatments will be administered once weekly by subcutaneous injections. Subjects will received treatment for 12 weeks and then be followed for an additional 6 weeks to assess the durability of the response.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 12-week Dose-Ranging Trial of IMO-8400 in Patients With Moderate to Sever Plaque Psoriasis
Study Start Date : May 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: IMO-8400 regimen 1
IMO 8400 at 0.075 mg/kq q wk x 12 wks
Drug: IMO-8400
IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection

Experimental: IMO-8400 Regimen 2
IMO-8400 at 0.15 mg/kg q wk x 12 wks
Drug: IMO-8400
IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection

Experimental: IMO-8400 Regimen 3
IMO_8400 at 0.3 mg/kg q wk x 12 wks
Drug: IMO-8400
IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection

Placebo Comparator: Placebo
Saline (placebo) q wk x 12 wks
Drug: Saline Placebo
Saline q wk x 12 wk by subcutaneous injection




Primary Outcome Measures :
  1. Determine the safety and tolerabity assessing AEs, Vital signs, physical exams and lab tests [ Time Frame: 18 weeks (12 wk treatment + 6 wk follow-up) ]
    Evaluation of safety and tolerability of different dose levels of IMO-8400 compared to placebo administered for 12 weeks to patients with moderate to severe plaque psoriasis


Secondary Outcome Measures :
  1. Assessment of psoriasis utilizing PASI, PGA, BSA scores and Dermatology Life Quality Index [ Time Frame: 18 weeks (12 wk treatment + 6 wk follow-up) ]
    To evaluate the treatment effect of different dose levels of IMO-8400 compared to placebo



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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:

  1. Is age 18 to 70 years, inclusive
  2. Completes the informed consent procedure (see Section 15.2), including signing and dating the informed consent form
  3. Has moderate to severe plaque psoriasis meeting the criteria specified above
  4. Is willing and able to comply with the restrictions detailed above
  5. Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment
  6. Female subjects of childbearing potential (see Section 8.2) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.2) from Screening through the treatment period and for ninety (90) days after the last injection of study drug

Exclusion Criteria:

  1. Has known hypersensitivity to any oligodeoxynucleotide
  2. Is nursing
  3. Has body weight <50 kg
  4. Has BMI >34.9 kg/m2
  5. Regularly consumes >3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day
  6. Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus (HCV)
  7. Has a positive test for hepatitis B surface antigen (HBsAg)
  8. Has at screening safety laboratory tests meeting one or more of the following criteria:

    • hemoglobin <6.52 mmol/L (<10.5 g/dL)
    • white blood cell count <4x109/L ( <4,000/mm3)
    • absolute neutrophil count (ANC) <1.5x109/L (<1500/mm3)
    • platelet count <100x109/L (<100,000/mm3 )
    • serum creatinine >1.3x ULN;
    • alanine transaminase (ALT; SGPT) >2.5x ULN
    • aspartate transaminase (AST; SGOT) >2.5x ULN
    • serum total bilirubin >1.4x ULN (except if consistent with Gilbert's disease: i.e., total bilirubin <103 μmol/L (6 mg/dL) and conjugated bilirubin <1.2x ULN)
  9. Has a history of allogeneic organ transplant (including bone marrow or stem cells)
  10. Has, within the past 10 years, had evidence of or required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ)
  11. Has had within the past three months or is expected to have during the study period any of the following treatments:

    • surgery requiring general anesthesia
    • hematopoietic stimulating agents (e.g., erythropoietin, G-CSF, GM-CSF)
    • another investigational drug;
  12. Has other significant medical conditions (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; uncontrolled diabetes
  13. Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial

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): NCT01899729


Locations
Netherlands
Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
Principal Investigator: Koos J Burggraaf, MSc, MD, PhD Center Human Drug Research, Leiden, Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01899729     History of Changes
Other Study ID Numbers: 8400-201
2013-000164-28 ( EudraCT Number )
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: July 2013

Keywords provided by Idera Pharmaceuticals, Inc.:
plaque psoriasis
autoimmune disease
Toll like receptor

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases