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.
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- STATUS
- Recruiting
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, Eczema (Atopic Dermatitis), Atopic Dermatitis |
|---|---|
| Clinical Study Identifier | TX218018 |
| Last Modified on | 23 November 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete 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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