Protocol summary

Study aim
This trial will be conducted to test the hypothesis that baricitinib 4-mg daily in combination with TCS is superior to azathioprine 1.5-2.5 mg/kg a day in combination with TCS for moderate-to-severe AD at week 12 in terms of efficacy and safety.
Design
Study BAAZ-AD-IR is a single-center, randomized, parallel-group, open-label, outpatient trial
Settings and conduct
In this study, patients with moderate to severe atopic dermatitis (eczema) who refer to the specialized clinic of Bo Ali Hospital located in Sari city of Mazandaran province and meet the inclusion criteria will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a minimum age of 18 years and maximum 75 years at the time of informed consent Patients with moderate to severe atopic dermatitis which is defined as having Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) ≥ 3, and body surface area (BSA) affected ≥10% Exclusion criteria: Patients who are currently suffering from or have a history of any concurrent skin disorders that would interfere with assessments of the study medication's effect on atopic dermatitis. Patients who have a known hypersensitivity to baricitinib or azathioprine or any component of these investigational products
Intervention groups
Intervention group: Group A includes patients who will receive baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks. Intervention group: Group B includes patients who will receive azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks.
Main outcome variables
Eczema Area and Severity Index (EASI)

General information

Reason for update
Acronym
BAAZ-AD-IR
IRCT registration information
IRCT registration number: IRCT20160427027636N6
Registration date: 2023-08-12, 1402/05/21
Registration timing: prospective

Last update: 2023-08-12, 1402/05/21
Update count: 0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Ghasem Rahmatpour Rokni
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3322 1755
Email address
gh.rahmatpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-15, 1402/05/24
Expected recruitment end date
2024-08-14, 1403/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of Baricitinib versus Azathioprine in Combination with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis Patients: Randomized Clinical Trial
Public title
Baricitinib versus Azathioprine in Moderate-to-Severe Atopic Dermatitis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a minimum age of 18 years and maximum 75 years at the time of informed consent Patients who can read, understand, and provide written informed consent Individuals with atopic dermatitis who have had a diagnosis for at least 12 months before to screening, as defined by the American Academy of Dermatology: Guidelines of care for the management of atopic dermatitis; Section 1. Diagnosis and assessment of atopic dermatitis Patients with moderate to severe atopic dermatitis which is defined as having Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) ≥ 3, and body surface area (BSA) affected ≥10% Individuals who have a documented history of insufficient response to topical treatments (at least a moderate potency topical corticosteroids and/or cyclosporine for at least 4 weeks or the maximum duration recommended for the product prescribed) within the 6 months before screening determined by a dermatologist
Exclusion criteria:
Patients who are currently suffering from or have a history of any concurrent skin disorders that would interfere with assessments of the study medication's effect on atopic dermatitis. For example, psoriasis or lupus erythematosus or eczema herpeticum, or erythrodermic, refractory, or unstable skin disease, including, but not limited, eczema that requires hospitalizations and/or intravenous treatment for skin infections Patients who have a known hypersensitivity to baricitinib or azathioprine or any component of these investigational products Patients with any major concomitant disease that is expected to need the administration of systemic corticosteroids, such as unstable chronic asthma, or who otherwise interfere with trial participation or require active regular monitoring. Patients who have been treated (1) Treatment with azathioprine in the previous 3 months (2) Having an experience of treatment with any oral JAK inhibitors including baricitinib < 4 weeks prior to randomization (3) Fusion proteins that target inflammatory pathways or monoclonal antibodies for less than 5 half-lives before randomization (4) Any parenteral corticosteroid administered by intramuscular/intravenous/intra-articular injection within 6 weeks before randomization or is anticipated to require a parenteral injection of corticosteroids during the study (5) probenecid at the time of randomization that cannot be discontinued for the duration of the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated randomly in a 1:1 ratio to either Baricitinib Azathioprine by using blocks of four which were generated via randomization.com (Block balanced randomization) and then imputed into the sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients who meet the eligibility criteria will be randomized in a 1:1 allocation ratio to enroll in this study.Before randomization, patients will be screened based on inclusion and exclusion criteria and will discontinue tropical and systemic treatments for atopic dermatitis for 2-weeks (washout period) and will not be allowed to use them during the study. In visit 1 which will be scheduled after the washout period, demographic information and baseline assessment will be conducted and patients will randomize into arms, baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream (Arm A), azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream (Arm B). Six weeks after visit 1, Visit 2 will be set to follow up on the patient condition, particularly in terms of adverse effects, and reorder their intervention. Visit 3 will be 12 weeks after visit 1 to perform the final assessment.Laboratory tests will be collected at baseline (as part of eligibility criteria) and final assessment.

Secondary Ids

1

Registry name
www.clinicaltrial.gov
Secondary trial Id
NCT05969730
Registration date
2023-07-23, 1402/05/01

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Mazandaran University of Medical Sciences
Street address
15th Khordad avenue-Barab clinic- Sari -Iran
City
Sari
Province
Mazandaran
Postal code
1234567898
Approval date
2023-07-12, 1402/04/21
Ethics committee reference number
IR.MAZUMS.REC.1402.214

Health conditions studied

1

Description of health condition studied
Moderate-to-Severe Atopic Dermatitis Patients
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis

Primary outcomes

1

Description
Eczema Area and Severity Index (EASI)
Timepoint
12 weeks
Method of measurement
Through physician assessment using the EASI form

Secondary outcomes

1

Description
Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD)
Timepoint
12 weeks
Method of measurement
Physician assessment using the vIGA-AD form

2

Description
SCORing Atopic Dermatitis (SCORAD)
Timepoint
12 weeks
Method of measurement
Physician assessment using the SCORAD form

3

Description
Dermatology Life Quality Index (DLQI)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

4

Description
Itch Numeric Rating Scale (Itch NRS)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

5

Description
Skin Pain Numeric Rating Scale (Skin Pain NRS)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

6

Description
Atopic Dermatitis Sleep Scale (ADSS)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

7

Description
Patient-Oriented Eczema Measure (POEM)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

8

Description
Hospital Anxiety Depression Scale (HADS)
Timepoint
12 weeks
Method of measurement
Patients Reported Outcome (PRO)

Intervention groups

1

Description
Intervention group: Group A includes patients who will receive baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: Group B includes patients who will receive azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Dermatology, Bou-Ali Sina Hospital
Full name of responsible person
Ghasem Rahmatpour Rokni
Street address
Mazandaran Province, Sari, Pasdaran Blvd, H23J+9PJ, 48158 38477, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Fax
+98 11 3334 3011
Email
Bou_Ali_hospital@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ghasem Rahmatpour Rokni
Street address
Sari, Pasdaran Blvd, H23J+9PJ
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Fax
+98 11 3334 3011
Email
Bou_Ali_hospital@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Malekan
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Ave. 8th
City
Sari
Province
Mazandaran
Postal code
4896413254
Phone
+98 911 755 4873
Email
malekan.mohammad78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Malekan
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Ave. 8th
City
Sari
Province
Mazandaran
Postal code
4896413254
Phone
+98 911 755 4873
Email
malekan.mohammad78@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Malekan
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Ave. 8th
City
Sari
Province
Mazandaran
Postal code
4896413254
Phone
+98 911 755 4873
Email
malekan.mohammad78@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study report in the form of an article, the English protocol of the study and the raw data of the study will be available for publication after completion.
When the data will become available and for how long
Permanently
To whom data/document is available
All readers and researchers
Under which criteria data/document could be used
For transparency and reuse in systematic analyses
From where data/document is obtainable
Mohammad Malekan malekan.mohammad78@gmail.com
What processes are involved for a request to access data/document
By email with the approval of the group active in the study
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