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Trial Outcomes & Findings for A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT01899729)

NCT ID: NCT01899729

Last Updated: 2022-04-07

Results Overview

The number of adverse events related and not related to treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

19 weeks (12 weeks on treatment + 7 week follow up)

Results posted on

2022-04-07

Participant Flow

Participant milestones

Participant milestones
Measure
IMO-8400 Regimen 1
IMO-8400 at 0.075 mg/kq q wk x 12 wks IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2
IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3
IMO-8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4
IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Placebo
Saline (placebo) q wk x 12 wks Saline Placebo: Saline q wk x 12 wk by subcutaneous injection
Overall Study
STARTED
9
9
8
9
11
Overall Study
COMPLETED
7
7
6
9
9
Overall Study
NOT COMPLETED
2
2
2
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
IMO-8400 Regimen 1
IMO-8400 at 0.075 mg/kq q wk x 12 wks IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2
IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3
IMO-8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4
IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Placebo
Saline (placebo) q wk x 12 wks Saline Placebo: Saline q wk x 12 wk by subcutaneous injection
Overall Study
Adverse Event
1
0
0
0
1
Overall Study
Withdrawal by Subject
1
2
0
0
0
Overall Study
Lack of Efficacy
0
0
2
0
1

Baseline Characteristics

A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IMO-8400 Regimen 1
n=9 Participants
IMO-8400 at 0.075 mg/kq q wk x 12 wks IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2
n=9 Participants
IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3
n=8 Participants
IMO-8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4
n=9 Participants
IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Placebo
n=11 Participants
Saline (placebo) q wk x 12 wks Saline Placebo: Saline q wk x 12 wk by subcutaneous injection
Total
n=46 Participants
Total of all reporting groups
Age, Continuous
53 years
n=39 Participants
31 years
n=41 Participants
42.5 years
n=35 Participants
45 years
n=31 Participants
44 years
n=146 Participants
44 years
n=19 Participants
Sex: Female, Male
Female
4 Participants
n=39 Participants
3 Participants
n=41 Participants
2 Participants
n=35 Participants
1 Participants
n=31 Participants
2 Participants
n=146 Participants
12 Participants
n=19 Participants
Sex: Female, Male
Male
5 Participants
n=39 Participants
6 Participants
n=41 Participants
6 Participants
n=35 Participants
8 Participants
n=31 Participants
9 Participants
n=146 Participants
34 Participants
n=19 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
0 Participants
n=19 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
0 Participants
n=41 Participants
2 Participants
n=35 Participants
0 Participants
n=31 Participants
2 Participants
n=146 Participants
4 Participants
n=19 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
0 Participants
n=19 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
0 Participants
n=19 Participants
Race (NIH/OMB)
White
5 Participants
n=39 Participants
8 Participants
n=41 Participants
6 Participants
n=35 Participants
9 Participants
n=31 Participants
8 Participants
n=146 Participants
36 Participants
n=19 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
1 Participants
n=146 Participants
3 Participants
n=19 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
3 Participants
n=19 Participants
Region of Enrollment
Netherlands
9 participants
n=39 Participants
9 participants
n=41 Participants
8 participants
n=35 Participants
9 participants
n=31 Participants
11 participants
n=146 Participants
46 participants
n=19 Participants
Body Mass Index
26.5 kg/m^2
n=39 Participants
21.2 kg/m^2
n=41 Participants
27.15 kg/m^2
n=35 Participants
27.7 kg/m^2
n=31 Participants
30.9 kg/m^2
n=146 Participants
27.2 kg/m^2
n=19 Participants

PRIMARY outcome

Timeframe: 19 weeks (12 weeks on treatment + 7 week follow up)

Population: Safety population

The number of adverse events related and not related to treatment

Outcome measures

Outcome measures
Measure
IMO-8400 Regimen 1
n=9 Participants
IMO 8400 at 0.075 mg/kq q wk x 12 wks IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2
n=9 Participants
IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3
n=8 Participants
IMO-8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4
n=9 Participants
IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Placebo
n=11 Participants
Saline (placebo) q wk x 12 wks Saline Placebo: Saline q wk x 12 wk by subcutaneous injection
Safety and Tolerability of IMO-8400 Compared With Placebo
AE Related to Treatment
6 adverse events
6 adverse events
6 adverse events
5 adverse events
6 adverse events
Safety and Tolerability of IMO-8400 Compared With Placebo
AE Not Related to Treatment
3 adverse events
3 adverse events
2 adverse events
4 adverse events
5 adverse events

Adverse Events

IMO-8400 Regimen 1

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

IMO-8400 Regimen 2

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

IMO-8400 Regimen 3

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

IMO-8400 Regimen 4

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
IMO-8400 Regimen 1
n=9 participants at risk
IMO 8400 at 0.075 mg/kq q wk x 12 wks IMO-8400 Regimen 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2
n=9 participants at risk
IMO-8400 at 0.15 mg/kg q wk x 12 wks IMO-8400 Regimen 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3
n=8 participants at risk
IMO\_8400 at 0.3 mg/kg q wk x 12 wks IMO-8400 Regimen 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4
n=9 participants at risk
IMO-8400 at 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Placebo
n=11 participants at risk
Saline (placebo) q wk x 12 wks Saline Placebo: Saline q wk x 12 wk by subcutaneous injection
General disorders
Influenza like illness
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
33.3%
3/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
25.0%
2/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Injection site hematoma
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
37.5%
3/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
18.2%
2/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Fatigue
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
33.3%
3/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Injection site pruritis
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Injection site pain
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Injection site erythema
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
General disorders
Injection site induration
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Nervous system disorders
Headache
44.4%
4/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
33.3%
3/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
25.0%
2/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
44.4%
4/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
45.5%
5/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Nervous system disorders
Somnolence
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Nervous system disorders
Dizziness
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Gastrointestinal disorders
Diarrhea
33.3%
3/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Gastrointestinal disorders
Nausea
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Gastrointestinal disorders
Abdominal discomfort
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Gastrointestinal disorders
Vomiting
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Musculoskeletal and connective tissue disorders
Back pain
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Infections and infestations
Upper respiratory tract infection
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Psychiatric disorders
Insomnia
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
22.2%
2/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
12.5%
1/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
9.1%
1/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
Renal and urinary disorders
Polyuria
0.00%
0/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/8 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
11.1%
1/9 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
0.00%
0/11 • From first dose of study treatment to Study Day 113.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a subject, whether or not the event is considered causally related to the medical product. An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.

Additional Information

Idera Medical Monitor

Idera Pharmaceuticals, Inc.

Phone: 617-679-5500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place