Trial Outcomes & Findings for Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis (NCT NCT01941537)

Results Overview

Percentage Change in the Scoring of Atopic Dermatitis (SCORAD) at week 12 compared to baseline in both arms of the study in subjects with atopic dermatitis. SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments \[itchy 0 (no itching) to 3 (severe itching) and sleep disturbance 0(no sleep disturbance) to 3 (severe sleep disturbance)\], and c) 6 disease intensity assessments \[dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	ILV-094 Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10). ILV-094: IV infusion of ILV-094	Placebo Comparator Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Overall Study STARTED	40	20
Overall Study COMPLETED	36	17
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ILV-094 Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10). ILV-094: IV infusion of ILV-094	Placebo Comparator Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	1	0
Overall Study Pregnancy	1	0
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ILV-094 n=40 Participants Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10). ILV-094: IV infusion of ILV-094	Placebo Comparator n=20 Participants Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.5 years STANDARD_DEVIATION 14.9 • n=5 Participants	41.3 years STANDARD_DEVIATION 16.3 • n=7 Participants	40.5 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Percentage Change in the Scoring of Atopic Dermatitis (SCORAD) at week 12 compared to baseline in both arms of the study in subjects with atopic dermatitis. SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments \[itchy 0 (no itching) to 3 (severe itching) and sleep disturbance 0(no sleep disturbance) to 3 (severe sleep disturbance)\], and c) 6 disease intensity assessments \[dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe).

Outcome measures

Outcome measures
Measure	ILV-094 n=40 Participants Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 Participants Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Percentage Change in SCORAD	-18.8 percentage change Standard Error 2.9	-11.7 percentage change Standard Error 3.9

SECONDARY outcome

Timeframe: 12 weeks

The SCORAD50 captures individuals who achieved 50% or greater improvement from baseline SCORAD score. This outcome measure is the percentage of participants who achieved SCORAD50 at week 12. This analysis will be performed using fisher exact test. Patients who drop-out will be considered treatment failures (non-responder approach). A sensitivity analysis will be carried out using data as observed.

Outcome measures

Outcome measures
Measure	ILV-094 n=40 Participants Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 Participants Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
The Percentage of Patients Who Achieve an Improvement of 50% or Greater From Their Baseline Objective SCORAD at Week 12 of ILV-094 Treatment	22.2 percentage of participants	15.0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

The (per-patient) percent improvement in the SCORAD relative to baseline, which will be analyzed using the MMRM approach described for the primary efficacy endpoint. Improvement is measured as the reduction in the score.

Outcome measures

Outcome measures
Measure	ILV-094 n=40 Participants Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 Participants Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
The (Per-patient) Percent Improvement in the SCORAD Relative to Baseline.	-13.8 percentage decline in SCORAD score Standard Error 2.7	-8.0 percentage decline in SCORAD score Standard Error 3.1

SECONDARY outcome

Timeframe: 12 weeks

Change in Investigator Global Assessment score (IGA) at week 12 as compared to baseline for both arms of the study in subjects with atopic dermatitis. IGA is a score between 0-5, with 0 being all clear, 1 being almost clear, 2 being mild disease, 3 being moderate disease, 4 being severe disease and 5 being very severe disease.

Outcome measures

Outcome measures
Measure	ILV-094 n=40 Participants Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 Participants Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Change in IGA Score	-0.6 score on a scale Standard Error 0.1	-0.3 score on a scale Standard Error 0.1

Adverse Events

ILV-094

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ILV-094 n=40 participants at risk Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 participants at risk Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Pregnancy, puerperium and perinatal conditions Pregnancy	5.0% 2/40 • Number of events 2 • 24 weeks	0.00% 0/20 • 24 weeks

Other adverse events

Other adverse events
Measure	ILV-094 n=40 participants at risk Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).	Placebo Comparator n=20 participants at risk Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10). Placebo Comparator: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Respiratory, thoracic and mediastinal disorders Mild Adverse Event	10.0% 4/40 • Number of events 4 • 24 weeks	0.00% 0/20 • 24 weeks

Additional Information

James Krueger

Rockefeller University

Phone: 2123277730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place