Effect of Tofacitinib Ointment 2% w/w compared to Pimecrolimus Cream 1% w/w in Patients with Mild to Moderate Atopic Dermatitis (AD).
Scientific Title of Study
A Multicenter, Prospective, Randomized, Open Label, Two-Arm, Parallel-Group, Phase III, Active Controlled, Non-inferiority, Comparative Study to Assess Efficacy and Safety of Tofacitinib Ointment 2% w/w to Pimecrolimus Cream 1% w/w in Patients with Mild to Moderate Atopic Dermatitis (AD).
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hemant Zaveri
Address
Building Name B wing, Corporate House Intas Pharmaceuticals Ltd.
Department name Medical Affairs
Floor No. 3rd floor
Corporate House, Near Sola Bridge,
S. G. Highway, Thaltej,
Ahmadabad GUJARAT 380054 India
Phone
07961577000
Fax
02717661106
Email
hemant_zaveri@intaspharma.com
Details Contact Person Scientific Query
Name
Dr Alok Chaturvedi
Address
Building Name B wing, Corporate House Intas Pharmaceuticals Ltd.
Department name Medical Affairs
Floor No. 3rd floor
Corporate House, Near Sola Bridge,
S. G. Highway, Thaltej,
Ahmadabad GUJARAT 380054 India
Phone
07961577000
Fax
02717661106
Email
alok_chaturvedi@intaspharma.com
Details Contact Person Public Query
Name
Dinesh Kumar Garg
Address
A-242,A-226, TTC Industrial Area, Near Mahape Depot,Mahape MIDC, Navi Mumbai
Thane MAHARASHTRA 400710 India
Phone
919152056548
Fax
Email
dinesh.garg@raptimresearch.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd.
Corporate House, Near Sola Bridge,
S. G. Highway, Thaltej,
Ahmedabad – 380054. Gujarat. India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Corporate House, Near Sola Bridge,
S. G. Highway, Thaltej,
Ahmedabad – 380054. Gujarat. India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Raptim Research Pvt Ltd
A-242,A-226, TTC Industrial Area, Near Mahape Depot,Mahape MIDC, Navi Mumbai – 400710, India
A thin layer of the product twice daily (approximately 12 ± 3 hours apart) to all AD affected areas
Intervention
Tofacitinib Ointment 2% w/w
A thin layer of the product twice daily (approximately 12 ± 3 hours apart) to all AD affected areas.
Total duration- 30 days
Inclusion Criteria
Age From
12.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Subjects will be eligible for inclusion in this study only if they meet all of the following criteria:
1. Male and female patients, age between 12-60 (both inclusive) years;
2. Have a clinical diagnosis of atopic dermatitis (AD) (also known as atopic eczema confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka) (Refer to Appendix-D);
3. Patients with mild to moderate AD based on vIGA-AD score of 2 (mild) or 3 (moderate) at Baseline (Refer to Appendix-C) ;
4. Have AD involvement ≥ 5% treatable body surface area (BSA) (excluding the scalp) and up to and including 20% of total BSA at Day 1 using Mostellar formulae;
5. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures;
In case of patients with age <18 years, legally acceptable representatives (LAR; e.g. parent/guardian/care-taker) must provide consent and Written Assent will be taken from patients if they are able to comprehend the nature of the study.
6. For female subjects: evidence of post-menopause, or, for females of child-bearing age, negative serum or urine pregnancy test prior to randomization;
7. Females of child-bearing age (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must agree to use highly effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with her partner during the study period and for 28 days following their last dose;
(Females who are not of childbearing potential are defined as:
i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); OR
ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR
iii. Have a congenital or acquired condition that prevents childbearing).
ExclusionCriteria
Details
Subjects will not be eligible for inclusion in this study if they meet any of the following criteria:
1. Currently experiencing or have a history of other concomitant skin conditions (like, lupus erythematosus, psoriasis or mycosis fungoides that requires frequent hospitalizations and/or continued treatment for skin infections;
2. Have clinically unstable AD or having consistent requirement for either oral, or parenteral (including topical) corticosteroids to manage AD signs and symptoms;
3. A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past;
4. Immunocompromised adults and adolescent, including subjects on systemic immunosuppressive medications;
5. Patients with a history of disseminated or recurrent herpes zoster infection;
6. Currently experiencing a skin infection or any other infection that requires treatment, or is currently being treated, with topical or systemic antibiotics;
7. Any clinically significant medical disorder, condition, or disease or clinically significant physical examination finding at screening visit that may interfere with study objectives/safety of the subjects;
8. Patients with history of Tuberculosis (TB) or living with contacts having TB in last 1 year;
9. Patients with history of lymphoproliferative disorders or malignancies (except adequately treated or excised nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ);
10. Patients already treated with phototherapy, systemic immunosuppresants, cytostatic drugs, systemic corticosteroid, oral Janus kinase (JAK) inhibitor, Monoclonal antibody, leukotriene antagonist, systemic antibiotics, or herbal medications with unknown properties or known beneficial effects for AD within 1 month prior to randomization;
11. Topical therapy (corticosteroids, tars, antihistamines, antibiotic creams, phosphodiesterase 4 [PDE4] inhibitors, retinoids or benzoyl peroxide products [BPO], antibacterial medications or antibacterial products included in soaps, bleach baths, or topical sodium hypochlorite-based products) within 14 days prior to randomization;
12. Use of other Investigational products used for the treatment of AD within 2 months prior to randomization;
13. Allergic to Tofacitinib or any macrolide or pimecrolimus or any excipients or any component of test/reference formulation;
14. Patients with HIV-positive, Hepatitis-B & C-positive;
15. Pregnant, lactating women and those planning to get pregnant;
16. Patients who participated in other clinical trials within 3 months prior to screening visit or not considered suitable for this trial by the researchers;
17. Patients/LAR who did not provide signed informed consent and adolescents who did not provide signed assent.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Test product Tofacitinib Ointment 2% w/w against pimecrolimus cream 1% w/w in patients with Mild to Moderate AD.
End of Week 4
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Tofacitinib Ointment 2% w/w in patients with mild to moderate AD.
End of Week 2 and Week 4.
Target Sample Size
Total Sample Size="184" Sample Size from India="184"
This
is a Multicenter, Prospective, Randomized, Open Label, Two-Arm, Parallel-Group,
Phase III, Active Controlled, Non-inferiority, Comparative Study to Assess
Efficacy and Safety of Tofacitinib Ointment 2% w/w to Pimecrolimus Cream 1% w/w
in Patients with Mild to Moderate Atopic Dermatitis (AD).
In
this study as per the routine clinical practice patients will be attending the
scheduled visits. So there will be total 6 visits, Visit 1: Screening/Washout
Period (Day -7 to Day -1), Visit 2: Baseline/Randomization Visit (Day 1), Visit
3: Follow up Visit (Day 7 ± 1), Visit 4: Follow up Visit (Day 14 ± 1), Visit 5:
Follow up Visit (Day 21 ± 1) & Visit 6: End of Treatment/Study Visit (Day
29 + 1). Apart from the scheduled visits, the patient can visit clinical site
on any day and this will be termed as unscheduled visit. This study will be
managed by Raptim Research Pvt Ltd.
