Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05656911
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-11-29
Brief Title:
A Study to Learn How Well the Study Treatment Zabedosertib BAY1834845 Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Parallel-group Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib BAY 1834845 for the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Damask
Brief Summary:
Researchers are looking for a better way to treat atopic dermatitis AD an often long-lasting inflammation of the skin Atopic dermatitis also called eczema is causing patches of skin to become swollen red cracked and itchy
The immune system helps protect the body from diseases But sometimes the immune system can be too sensitive and overreact This may then lead to allergies but also to skin conditions like atopic dermatitis
The study treatment zabedosertib BAY1834845 is currently under development for the treatment of atopic dermatitis and other inflammatory diseases It works by reducing the activity of a protein called IRAK4 IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells By reducing the activity of IRAK4 the inflammation reactions are expected to be reduced
The main purpose of the study is to learn how well zabedosertib works compared to placebo A placebo is a treatment that looks like a medicine but does not have any medicine in it How well it works means to find out the efficacy of zabedosertib To answer this the researchers will compare how many participants had 75 EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo EASI represents Eczema Area and Severity Index EASI It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body The score ranges from 0-72 with 0 meaning clear skin and 72 meaning severe atopic dermatitis In addition the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed
The secondary purpose of the study is to learn how safe it is compared to placebo To know this study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo
In the study participants will be randomly by chance assigned to receive zabedosertib or placebo The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks
The study consists of an up to 28-day screening period Visits 1 and 2 a 12-week treatment period consisting of 5 visits Visits 3 to 7 and a 4-week follow-up visits Visits 8 Thus the total study duration per participant will be 17 to 20 weeks approximately 140 days
During the study the study team will
take blood and urine samples
take skin samples not obligatory for all patients
check the participants disease area for assessment
provide participants device to record their disease status and to take pictures on their disease areas
have participants complete self-reported questionnaires
do physical examinations
examine heart health using ECG
check vital signs
ask the participants questions about how they are feeling and what events they are having
An adverse event is any problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
At 28 days after the participants take their last treatment the study team will check if participants have any events that might be related to the study treatment This will be the last visit for the study
The immune system helps protect the body from diseases But sometimes the immune system can be too sensitive and overreact This may then lead to allergies but also to skin conditions like atopic dermatitis
The study treatment zabedosertib BAY1834845 is currently under development for the treatment of atopic dermatitis and other inflammatory diseases It works by reducing the activity of a protein called IRAK4 IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells By reducing the activity of IRAK4 the inflammation reactions are expected to be reduced
The main purpose of the study is to learn how well zabedosertib works compared to placebo A placebo is a treatment that looks like a medicine but does not have any medicine in it How well it works means to find out the efficacy of zabedosertib To answer this the researchers will compare how many participants had 75 EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo EASI represents Eczema Area and Severity Index EASI It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body The score ranges from 0-72 with 0 meaning clear skin and 72 meaning severe atopic dermatitis In addition the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed
The secondary purpose of the study is to learn how safe it is compared to placebo To know this study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo
In the study participants will be randomly by chance assigned to receive zabedosertib or placebo The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks
The study consists of an up to 28-day screening period Visits 1 and 2 a 12-week treatment period consisting of 5 visits Visits 3 to 7 and a 4-week follow-up visits Visits 8 Thus the total study duration per participant will be 17 to 20 weeks approximately 140 days
During the study the study team will
take blood and urine samples
take skin samples not obligatory for all patients
check the participants disease area for assessment
provide participants device to record their disease status and to take pictures on their disease areas
have participants complete self-reported questionnaires
do physical examinations
examine heart health using ECG
check vital signs
ask the participants questions about how they are feeling and what events they are having
An adverse event is any problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
At 28 days after the participants take their last treatment the study team will check if participants have any events that might be related to the study treatment This will be the last visit for the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000520-38 | EUDRACT_NUMBER | None | None |