The purpose of this study is to compare the safety and effects, good or bad, of MSTT1041A versus placebo on patients with moderate to severe atopic dermatitis.

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

The purpose of this study is to compare the safety and effects, good or bad, of MSTT1041A versus placebo on patients with moderate to severe atopic dermatitis. 

Description

 In this study, you will get either MSTT1041A or placebo.  A placebo looks like a drug but has no active ingredient.   About 90 people will take part in this study.

MSTT1041A is an experimental drug, which means that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

 

You will be randomly placed in one of the following treatment groups:

  • Group 1 will receive MSTT1041A (490 mg, except Week 1, which is 245 mg)
  • Group 2 will receive placebo

 

Your group will be decided by chance (like tossing a coin). You will have an equal chance of being placed in any group. Neither you nor your study doctor can choose or know the group you are in. However, your study doctor can find out which group you are in, if your safety is at risk.  The study drug will be injected under your skin through a needle.  This is known as a subcutaneous (SC) injection.

 

Study personnel will administer four subcutaneous injections in four separate locations in your abdomen (belly) on Day 1 (first day of treatment) and Weeks 4, 8, and 12.  You will be given two subcutaneous injections in two separate locations in your abdomen at the Week 1 visit.  You will remain at the study site for at least 30 minutes after the injection of the study drug so that you can be observed for any reactions to the injections.

 

During this study, you will have 8 to 10 office visits and 4-5 phone visits. Visits may last approximately 1-2.5 hours. Your total time in the study will be about 6-7 months.

Main Points
  • Up to 35 day screening period. 16 week double-blinded treatment period and an 8 week follow up period.
  • Documented history of inadequate response to treatment with topical medications.
  • 1:1 ratio to receive MSTT1041A 490mg SC or placebo SC Q4W.
  • Compensation of $84 for visit 1, 2, 3, 5, 7, 9, 11 & 13 and compensation of $20 for visit 4, 6, 8, 10, & 12 (phone call).

Details
Condition ATOPIC DERMATITIS
Clinical Study IdentifierTX218018
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-75 years old
BMI of 18-40 kg/m2 and weight ≥ 40 kg at screening
Chronic AD that has been present for at least 3 years before the screening visit
EASI score ≥ 16; IGA score ≥ 3; BSA ≥ 10% at screening and the randomization visit
Pruritus NRS score ≥ 3 at screening and the randomization visit
Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of the study drug
Prior treatment with MSTT1041A
Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives before screening
Treatment with immunomodulatory, immunosuppressive within 4 weeks before screening
Treatment with any cell-depleting agents (i.e. rituximab) within 6 months before screening
Treatment with biologics within 3 months or 5 half-lives before screening
Regular use of tanning booth/phototherapy within 2 weeks before screening
Treatment with TCS or TCIs within 1 week before the randomization visit
Treatment with immunoglobulin, blood products, or live attenuated vaccines within 4 weeks before screening
Acute or chronic infection requiring either surgical or medical therapy within 2 weeks before screening or superficial skin infections within 1 week before randomization
Positive test for TB during screening
History of immunodeficiency disorder
Positive HCV at screening
Ineligible test results for HBsAg, HBsAb, and HBcAb at screening
Abnormal laboratory results
Active malignancy, including cutaneous basal or squamous cell carcinoma or melanoma
History of malignancy within 5 years before screening, exception for cases of cervical carcinoma in situ or breast ductal carcinoma in situ that have been treated and considered cured
Helminthic parasitic infection diagnosed within 6 months before screening
History of evidence of substance abuse
HbA1c > 8.5%
History of MI, congestive heart failure NHYA Class III and IV, unstable angina pectoris, or stroke within 12 months before screening
History or presence of complete LBBB, second- or third-degree AVB, or evidence of prior myocardial infarction on ECG
QTcF >450 ms, if patient is male, or QTcF > 470, if patient is female
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Planned surgical intervention during the course of the study
Patient who is a member of the investigational team or his/her immediate family
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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