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Trial record 21 of 810 for:    Psoriasis 4

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

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: NCT01622348
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : November 13, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Actively Extending Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Interventions Drug: IMO-3100 at 0.16 mg/kg
Drug: Saline for Injection
Drug: IMO-3100 at 0.32 mg/kg
Enrollment 44
Recruitment Details This was a multicenter study conducted at 13 study centers in the Unites States (US).
Pre-assignment Details 48 patients met inclusion/exclusion criteria; 4 were not randomized. The reasons for not randomizing these patients were: 2 patients withdrew consent, 1 whose calcium levels did not meet the criteria for randomization, and 1 for whom the study was closed prior to randomization
Arm/Group Title IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Hide Arm/Group Description

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

IMO-3100 at 0.16 mg/kg: 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 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

IMO-3100 at 0.32 mg/kg: 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

Saline for Injection

Saline for Injection: 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

Period Title: Overall Study
Started 15 14 15
Completed 14 14 14
Not Completed 1 0 1
Reason Not Completed
Withdrawal by Subject             1             0             1
Arm/Group Title IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo Total
Hide Arm/Group Description

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

IMO-3100 at 0.16 mg/kg: 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 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

IMO-3100 at 0.32 mg/kg: 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

Saline for Injection

Saline for Injection: 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

Total of all reporting groups
Overall Number of Baseline Participants 15 14 15 44
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 15 participants 44 participants
37.5  (13.76) 41.9  (12.54) 39.6  (13.15) 39.6  (13.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 44 participants
Female
6
  40.0%
11
  78.6%
11
  73.3%
28
  63.6%
Male
9
  60.0%
3
  21.4%
4
  26.7%
16
  36.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 44 participants
White
15
 100.0%
12
  85.7%
13
  86.7%
40
  90.9%
Black
0
   0.0%
2
  14.3%
2
  13.3%
4
   9.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 15 participants 44 participants
15
 100.0%
14
 100.0%
15
 100.0%
44
 100.0%
1.Primary Outcome
Title Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
Hide Description The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Hide Arm/Group Description:

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

IMO-3100 at 0.16 mg/kg: 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 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

IMO-3100 at 0.32 mg/kg: 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

Saline for Injection

Saline for Injection: 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

Overall Number of Participants Analyzed 15 14 15
Mean (Standard Deviation)
Unit of Measure: Millimeters
-8.8  (85.9) -48.5  (91.0) 17.3  (102.8)
Time Frame AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
Adverse Event Reporting Description

An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency.

  • Unfavorable and unintended symptom reported by the subject;
  • Clinical sign detected by the Investigator;
  • Abnormal result from a laboratory study or other diagnostic procedure;
 
Arm/Group Title IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Hide Arm/Group Description

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

IMO-3100 at 0.16 mg/kg: 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 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

IMO-3100 at 0.32 mg/kg: 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

Saline for Injection

Saline for Injection: 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

All-Cause Mortality
IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMO-3100 at 0.16 mg/kg IMO-3100 at 0.32 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/15 (40.00%)   8/14 (57.14%)   4/15 (26.67%) 
Eye disorders       
Sclera hemorrhage * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Gastrointestinal disorders       
Abdominal pain lower * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Diarrhea * 1  1/15 (6.67%)  2/14 (14.29%)  0/15 (0.00%) 
Nausea * 1  2/15 (13.33%)  0/14 (0.00%)  1/15 (6.67%) 
General disorders       
Chills * 1  0/15 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Injection site discoloration * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Injection site erythema * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Injection site pain * 1  1/15 (6.67%)  1/14 (7.14%)  1/15 (6.67%) 
Pyrexia * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Infections and infestations       
Infected bites * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Nasopharynghitis * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Tinea pedis * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Injury, poisoning and procedural complications       
Anthropod bite * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Incision site pain * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Investigations       
Albumin urine present * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/15 (0.00%)  2/14 (14.29%)  2/15 (13.33%) 
Back pain * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Joint swelling * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Muscle spasms * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Myalgia * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Nervous system disorders       
Headache * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Hypoasthenia * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Paraesthesia * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Tension headache * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Psychiatric disorders       
Panic attack * 1  0/15 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Nasal congestion * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Pulmonary congestion * 1  1/15 (6.67%)  0/14 (0.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash * 1  0/15 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Skin hyperpigmentation * 1  0/15 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Idera Medical Monitor
Organization: Idera Pharmaceuticals, Inc.
Phone: 617-679-5500
EMail: clinicaltrials@iderapharma.com
Layout table for additonal information
Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01622348     History of Changes
Other Study ID Numbers: 3100-202
First Submitted: May 21, 2012
First Posted: June 19, 2012
Results First Submitted: October 12, 2017
Results First Posted: November 13, 2017
Last Update Posted: January 9, 2018