Trial Outcomes & Findings for Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis (NCT NCT01806662)

Last Updated: 2018-03-14

Results Overview

Greater improvement from their baseline objective SCORAD (SCORing Atopic Dermatitis) at Week 16. The efficacy variable for each randomized group is the proportion of subjects who achieve an improvement of 50% or greater from their baseline objective SCORAD at Week 16 (at crossover). SCORAD-50 is the percentage of decrease in baseline SCOARD at Week 16. SCORAD is a clinical tool used to assess the extent and severity of eczema. Calculation is based on extent of involvement (skin involvement) and subjective symptoms of itching and loss of sleep. The SCORAD scale ranges from 0 (minimum, lowest possible score, Mild severity) to 103 (maximum, highest possible score, Severe severity) \[last observation carry forward\].

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Week 16

Results posted on

2018-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm (Ustekinumab First, Then Palcebo) Since there is a crossover design, each patient will be in the treatment arm for 32 weeks (16 weeks on Ustekinumab, then 16 weeks on Placebo) of the study. Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23	Placebo Arm (Placebo First, Then Ustekinumab) Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16 (for 16 weeks). Placebo: Injection of placebo
First Intervention (Weeks 0-16) STARTED	16	16
First Intervention (Weeks 0-16) Received Intervention	12	15
First Intervention (Weeks 0-16) COMPLETED	12	15
First Intervention (Weeks 0-16) NOT COMPLETED	4	1
Second Intervention (Weeks 16-32) STARTED	12	15
Second Intervention (Weeks 16-32) COMPLETED	10	11
Second Intervention (Weeks 16-32) NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm (Ustekinumab First, Then Palcebo) Since there is a crossover design, each patient will be in the treatment arm for 32 weeks (16 weeks on Ustekinumab, then 16 weeks on Placebo) of the study. Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23	Placebo Arm (Placebo First, Then Ustekinumab) Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16 (for 16 weeks). Placebo: Injection of placebo
First Intervention (Weeks 0-16) Withdrawal by Subject	4	0
First Intervention (Weeks 0-16) Adverse Event	0	1
Second Intervention (Weeks 16-32) Lack of Efficacy	2	3
Second Intervention (Weeks 16-32) Lost to Follow-up	0	1

Baseline Characteristics

Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=32 Participants Since there is a crossover design, each participant will be in the Treatment Arm (Ustekinumab first, Then Placebo) or Placebo Arm (Placebo first, Then Ustekinumab) for 16 weeks of the study. They will crossover to the other treatment at week 16 for 16 weeks (32 weeks total). Placebo: Injection of placebo Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Proportion of participants with improved outcome.

Outcome measures

Outcome measures
Measure	Treatment Arm (Ustekinumab First, Then Palcebo) n=16 Participants Since there is a crossover design, each patient will be in the treatment arm for 16 weeks of the study. Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23	Placebo Arm (Placebo First, Then Ustekinumab) n=16 Participants Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16. Placebo: Injection of placebo
Proportion of SCORAD-50 Response at Week 16.	5 Participants	3 Participants

Adverse Events

Ustekinumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

James Krueger

Rockefeller University

Phone: 2123278333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ustekinumab n=32 participants at risk Participants who received Ustekinumab injection for 16 weeks. Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23	Placebo n=32 participants at risk Participants who received Placebo injection for 16 weeks. Placebo: Injection of placebo
General disorders upper respiratory infection	9.4% 3/32 • Number of events 3 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Ear and labyrinth disorders ear infection	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
General disorders fall	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
General disorders musculoskeletal pain	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Skin and subcutaneous tissue disorders Skin infection	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	6.2% 2/32 • Number of events 2 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Skin and subcutaneous tissue disorders Contact dermatitis/allergy	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Skin and subcutaneous tissue disorders Eczema herpeticum flare	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Nervous system disorders Light Headed	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Infections and infestations Pneumonia	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Infections and infestations Urinary Tract Infection	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Skin and subcutaneous tissue disorders Eczema Flare	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	6.2% 2/32 • Number of events 2 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Immune system disorders Diaphoresis	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Gastrointestinal disorders Blood per rectum	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
General disorders Flu-like symptoms	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Gastrointestinal disorders Enteritis	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.
Nervous system disorders Headache	0.00% 0/32 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.	3.1% 1/32 • Number of events 1 • 16 weeks for each intervention. Adverse Event reporting included all participants who received at least one dose of intervention.