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Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01806662
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : December 19, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Ustekinumab
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow for 2 periods

Period 1:   First Intervention (Weeks 0-16)
    Treatment Arm (Ustekinumab First, Then Palcebo)   Placebo Arm (Placebo First, Then Ustekinumab)
STARTED   16   16 
Received Intervention   12   15 
COMPLETED   12   15 
NOT COMPLETED   4   1 
Withdrawal by Subject                4                0 
Adverse Event                0                1 

Period 2:   Second Intervention (Weeks 16-32)
    Treatment Arm (Ustekinumab First, Then Palcebo)   Placebo Arm (Placebo First, Then Ustekinumab)
STARTED   12   15 
COMPLETED   10   11 
NOT COMPLETED   2   4 
Lack of Efficacy                2                3 
Lost to Follow-up                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study 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


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      32 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 38.5 
 (18 to 61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  37.5% 
Male      20  62.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3   9.4% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      6  18.8% 
White      23  71.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Proportion of SCORAD-50 Response at Week 16.   [ Time Frame: Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James Krueger
Organization: Rockefeller University
phone: 2123278333
e-mail: gilleap@mail.rockefeller.edu



Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01806662     History of Changes
Other Study ID Numbers: JKR-0737
First Submitted: February 28, 2013
First Posted: March 7, 2013
Results First Submitted: August 17, 2017
Results First Posted: December 19, 2017
Last Update Posted: March 14, 2018