Trial of IMO-3100 in Patients With Moderate to Severe Pla... | NCT01622348

Status Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
serum creatinine > 1.3x ULN;
Has a history of allogeneic organ transplant (including bone marrow or stem cells);
Has, within the past 10 years, had evidence of or required treatment for cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ);
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;
Has other significant medical disease (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; chronic infection (e.g., tuberculosis); uncontrolled diabetes;
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.

Name	Affiliation	Role
Robert D Arbeit, MD	Idera Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Florida Center for Dermatology, P.A		Jacksonville	Florida	32204	United States
Atlanta Dermatology, Vein & Research Center, PC

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IMO-3100 at 0.16 mg/kg	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
FG001	IMO-3100 at 0.32 mg/kg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IMO-3100 at 0.16 mg/kg	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
BG001	IMO-3100 at 0.32 mg/kg	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
BG002	Placebo	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
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00015 BG00114 BG00215 BG00344

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

ITT population

Posted

Mean

Standard Deviation

Millimeters

8 weeks

ID	Title	Description
OG000	IMO-3100 at 0.16 mg/kg	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
OG001	IMO-3100 at 0.32 mg/kg	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
OG002	Placebo	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

Units	Counts
Participants	OG00015 OG00114 OG00215

Title

Denominators

Categories

Title	Measurements
	OG000-8.8± 85.9 OG001-48.5± 91.0 OG00217.3± 102.8

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IMO-3100 at 0.16 mg/kg	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	15	15	6	15
EG001	IMO-3100 at 0.32 mg/kg	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	14	14	8	14
EG002	Placebo	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	15	15	4	15

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sclera hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0020 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0021 affected15 at risk
Chills	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected15 at risk
Injection site discoloration	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Injection site erythema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Injection site pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0021 affected15 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Infected bites	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Nasopharynghitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Tinea pedis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Anthropod bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Albumin urine present	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0022 affected15 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Hypoasthenia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Paraesthesia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk
Tension headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Panic attack	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected15 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected15 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected15 at risk

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D012965	Sodium Chloride
D007267	Injections

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics