A Study will be conducted in Patients with Moderate to Severe Atopic Dermatitis using Tacrolimus 0.03% Topical Ointment

Phase 3

Not yet recruiting

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2022/08/045019
• Lead Sponsor: Intas Pharmaceuticals Limited India

Brief Summary

A Randomized, Double-Blind, Vehicle-Controlled, Three arm, Parallel Group, Multi-Centric, Clinical Study to Establish the Therapeutic Equivalence of Tacrolimus 0.03% Topical Ointment of Intas Pharmaceuticals Limited with Protopic® 0.03% Topical Ointment in Patients with Moderate to Severe Atopic Dermatitis

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Participants are eligible to be included in the study only if all the following criteria apply: 1 Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Man or woman participant must be aged 18 years or older, at the time of signing the informed consent.3 Participants who are medically stable on the basis of physical examination, medical history, and vital signs performed at screening.
• Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.4 Participants who are medically stable on the basis of clinical laboratory tests performed at screening.
• If the results of the serum biochemistry panel, hematology assessments are outside the normal reference ranges, the participant may be included if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study.This determination must be recorded in the participant source documents and initialed by the investigator.5 A diagnosis of atopic dermatitis for at least 3 months (participant may verbally report signs and symptoms of atopic dermatitis with an onset at least 3 months prior to screening visit)6 Clinical diagnosis of moderate to severe atopic dermatitis (AD), as defined by the criteria of Hanifin and Rajka at screening visit• Affected area of AD involvement must be at least 10per cent body surface area (BSA) at baseline visit.7 A validated Investigator Global Assessment (vIGA) of disease severity of at least moderate at baseline visit (vIGA assessment score of 3 or 4).8 Participants must have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable in the opinion of investigator.
• (Participant verbal report of failure to other topical prescription treatments for AD can be considered.)9 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies- • Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of more than 1 percent per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 16 days,after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 16 days after the last dose of study intervention.
• The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.• A WOCBP must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and urine beta-hCG test at baseline.•If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
• In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.10 Male participants are eligible to participate if they agree to the following during the intervention period and for at least 16 days after the last dose of study intervention:•Must agree not to donate sperm for the purpose of reproduction.PLUS EITHER•Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.OR•Must agree to use contraception /barrier as detailed below− a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person − male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.11 Willing and able to adhere to the lifestyle restrictions specified in this protocol.

Exclusion Criteria

• 1 Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specifiedassessments.
• 2 Known allergies, hypersensitivity, or intolerance to tacrolimus topical ointment or its excipients (refer to the product monograph of Protopic®) 3 Contraindications to the use of tacrolimus 0.03% topical ointment per product monograph of Protopic®.
• 4 Has documented medical history or current evidence of positive hepatitis B surface antigen (HBsAg) at screening.
• • Has documented medical history or current evidence of positive hepatitis C antibody at screening.
• 6 Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
• 7 Clinically significant severe renal insufficiency or severe hepatic disorders as judged by the investigator.
• 8 Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis as judged by the investigator) requiring oral antimicrobials within 14 days prior to baseline and topical antimicrobials within 7 days prior to baseline.
• 9 Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations in the opinion of the investigator.
• 10 History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis in the areas affected by atopic dermatitis or who are judged inappropriate for assessment of AD in the present study as per investigator’s discretion.
• 11 Participant with a known case of genetic epidermal barrier defect such as Netherton’s syndrome.
• 12 History or known case of congenital or acquired immunodeficiencies, which in the investigator’s opinion would contraindicate the use of immunosuppressants.
• 13 Presence of serious active infection (use of IV antimicrobials or invasive procedures required for treatment), or recurrent infection as judged by the investigator, within last 14 days from baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-To establish the therapeutic equivalence between tacrolimus-test and tacrolimus-reference in participants with moderate to severe atopic dermatitis.-To establish superiority of tacrolimus-test and tacrolimus-reference over vehicle in participants with moderate to severe atopic dermatitis	-Proportion of participants with treatment success based on validated Investigator Global | Assessment scale for Atopic Dermatitis at the end of treatment (Day 29).− Treatment success is defined as a grade of clear or almost clear; a score of 0 or 1, within all treatment areas

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of tacrolimus-test,tacrolimus-reference and vehicle in participants with moderate to severe atopic dermatitis	• Mean change from baseline to end of treatment(Day 29) in severity of four individual signs and symptoms of AD (i.e., erythema,induration/papulation, lichenification and pruritus)

Trial Locations

Locations (20)

Ajanta Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Amena Khatun Multi-Speciality Hospital, Sarkhej Road.; 🇮🇳 Ahmadabad, GUJARAT, India

B.J. Govt. Medical College And Sassoon General Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dr. D.Y.Patil Medical College, Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

GBH Memorial Cancer Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

GSVM Medical College, Kanpur/LLR Hospital; 🇮🇳 Jalaun, UTTAR PRADESH, India

Jupiter Hospital and Research Centre; 🇮🇳 Vadodara, GUJARAT, India

K R Hospital MMC & RI Mysuru; 🇮🇳 Mysore, KARNATAKA, India

Khyati Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

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Ajanta Research Center

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Amit Madan

Principal investigator

9030001239

amitmadan_2000@yahoo.com