Actively Extending Plaque PsoriasisPhase 2NCT01622348

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

A Phase 2 study testing IMO-3100 at 0.16 mg/kg, Saline for Injection and IMO-3100 at 0.32 mg/kg in people with Actively Extending Plaque Psoriasis and Moderate to Severe Plaque Psoriasis, run by Idera Pharmaceuticals, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
What is being tested?: IMO-3100 at 0.16 mg/kg, Saline for Injection and IMO-3100 at 0.32 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 13 sitesUnited States
Study dates: May 2012to Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Atlanta Dermatology, Vein & Research Center, PC
Alpharetta, Georgia, 30022
Tufts Medical Center
Boston, Massachusetts, 02111
Mass General Hospital Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02199
J & S Studies
College Station, Texas, 77845
Florida Center for Dermatology, P.A
Jacksonville, Florida, 32204
Clinical Partners, Inc
Johnston, Rhode Island, 02919
DermResearch PLLC
Louisville, Kentucky, 40217
Dermatologic Surgery Specialists, Inc.
Macon, Georgia, 31217
Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
University of Utah, Dermatology
Salt Lake City, Utah, 84132
Derm Research Center of New York
Stony Brook, New York, 11790
Center for Clinical Studies
Webster, Texas, 77598

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

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.

Read the detailed description

To evaluate the safety, tolerability and treatment effect of 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
Being tested: IMO-3100 at 0.16 mg/kg, Saline for Injection, IMO-3100 at 0.32 mg/kg
Keywords: Psoriasis, Plaque Psoriasis
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMO-3100 at 0.16 mg/kgDrug
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
Saline for InjectionDrug
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
IMO-3100 at 0.32 mg/kgDrug
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

Study groups in NCT01622348
Study group	Role	What they receive
Placebo	Placebo comparator	Saline for Injection Receives: 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 Receives: 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 Receives: Drug: IMO-3100 at 0.32 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Dec 2012

First posted19 Jun 2012 (estimated)
Study startMay 2012
Primary completionNov 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Actively Extending Plaque PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01622348
Sponsor's protocol ID: 3100-202
Status last verified: Dec 2017
First submitted: 21 May 2012
Last updated: 9 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT01622348
Acronym / sponsor ID: 3100-202
Conditions: Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis, Plaque Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 19 Jun 2012 (estimated)
Results: Posted 13 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

To evaluate the safety, tolerability and treatment effect of different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Saline for InjectionSaline for Injection
IMO-3100 at 0.16 mg/kg	Active comparator	Drug: IMO-3100 at 0.16 mg/kgIMO-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 0.32 mg/kg	Active comparator	Drug: IMO-3100 at 0.32 mg/kgIMO-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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (24 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMO-3100 at 0.16 mg/kgIMO-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	Drug	IMO-3100 at 0.16 mg/kg
Saline for InjectionSaline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL	Drug	Placebo
IMO-3100 at 0.32 mg/kgIMO-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	Drug	IMO-3100 at 0.32 mg/kg

Primary outcome

Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
Time frame: 8 weeks
The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion

Results and safety

Results posted to the registry on 13 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IMO-3100 at 0.16 mg/kg	15	14
IMO-3100 at 0.32 mg/kg	14	14
Placebo	15	14

Primary outcome: Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Millimeters

Measure	IMO-3100 at 0.16 mg/kg n = 15	IMO-3100 at 0.32 mg/kg n = 14	Placebo n = 15
Value	-8.8 (85.9)	-48.5 (91.0)	17.3 (102.8)

Population analysed: ITT population

Adverse events

Time frame: AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IMO-3100 at 0.16 mg/kg	0 of 15 (0%)	6 of 15 (40%)	0 of 15
IMO-3100 at 0.32 mg/kg	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14
Placebo	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert D Arbeit, MD study director

Idera Pharmaceuticals, Inc.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01622348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.