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

• ClinicalTrials.gov Identifier: NCT01941537
• Recruitment Status: Completed
• First Posted: September 13, 2013
• Results First Posted: May 7, 2019
• Last Update Posted: May 7, 2019
• Sponsor: Rockefeller University
• Collaborator: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Rockefeller University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis
• Interventions: Drug: ILV-094; Drug: Placebo Comparator
• Enrollment: 60

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	ILV-094	Placebo Comparator
Arm/Group Description	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	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).
Period Title: Overall Study
Started	40	20
Completed	36	17
Not Completed	4	3
Reason Not Completed
Lack of Efficacy	1	2
Lost to Follow-up	1	0
Pregnancy	1	0
Adverse Event	1	0
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		ILV-094	Placebo Comparator	Total
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		40	20	60
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	20 participants	60 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	40 100.0%	20 100.0%	60 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	40 participants	20 participants	60 participants
		40.5 (14.9)	41.3 (16.3)	40.5 (15.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	20 participants	60 participants
	Female	17 42.5%	11 55.0%	28 46.7%
	Male	23 57.5%	9 45.0%	32 53.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	40 participants	20 participants	60 participants
		40	20	60

Outcome Measures

1. Primary Outcome

Title	Percentage Change in SCORAD
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ILV-094	Placebo Comparator
Arm/Group Description:	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).	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 Number of Participants Analyzed	40	20
Mean (Standard Error); Unit of Measure: percentage change
	-18.8 (2.9)	-11.7 (3.9)

2. Secondary Outcome

Title	The Percentage of Patients Who Achieve an Improvement of 50% or Greater From Their Baseline Objective SCORAD at Week 12 of ILV-094 Treatment
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ILV-094	Placebo Comparator
Arm/Group Description:	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).	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 Number of Participants Analyzed	40	20
Measure Type: Number; Unit of Measure: percentage of participants
	22.2	15.0

3. Secondary Outcome

Title	The (Per-patient) Percent Improvement in the SCORAD Relative to Baseline.
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ILV-094	Placebo Comparator
Arm/Group Description:	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	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 Number of Participants Analyzed	40	20
Mean (Standard Error); Unit of Measure: percentage decline in SCORAD score
	-13.8 (2.7)	-8.0 (3.1)

4. Secondary Outcome

Title	Change in IGA Score
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ILV-094	Placebo Comparator
Arm/Group Description:	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	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 Number of Participants Analyzed	40	20
Mean (Standard Error); Unit of Measure: score on a scale
	-0.6 (0.1)	-0.3 (0.1)

Adverse Events

Time Frame	24 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ILV-094		Placebo Comparator
Arm/Group Description	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).		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).
All-Cause Mortality
	ILV-094		Placebo Comparator
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	ILV-094		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/40 (5.00%)		0/20 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy † 1 [1]	2/40 (5.00%)	2	0/20 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (3.0); [1] Pregnancy
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ILV-094		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/40 (10.00%)		0/20 (0.00%)
Respiratory, thoracic and mediastinal disorders
Mild Adverse Event † 1 [1]	4/40 (10.00%)	4	0/20 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (3.0); [1] Upper respiratory infection

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: James Krueger
• Organization: Rockefeller University
• Phone: 2123277730
• EMail: kruegej@rockefeller.edu

• Responsible Party: Rockefeller University
• ClinicalTrials.gov Identifier: NCT01941537 History of Changes
• Other Study ID Numbers: JKR-0766
• First Submitted: August 29, 2013
• First Posted: September 13, 2013
• Results First Submitted: January 10, 2019
• Results First Posted: May 7, 2019
• Last Update Posted: May 7, 2019