Include more sites from govt hospitals: CDSCO panel tells Intas on Tofacitinib Ointment 2% CT study
New Delhi: Directing the pharma major Intas Pharma to include more study sites from government hospitals geographically distributed in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to conduct a Phase III clinical trial of Tofacitinib Ointment 2%.
This nod is subject to conditions that post trial access to standard of care to the patients should be included in the clinical trial protocol for patient's safety. Further the conditions include the the firm should present the data of first 50 patients (equally distributed in each arm) enrolled in the study for review by the committee, prior to further recruitment of the patients in the clinical trial.
This came after the pharma major Intas Pharma presented the Phase III clinical trial protocol before the committee as part of manufacturing and marketing permission of Tofacitinib Ointment 2%.
Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It acts by decreasing the activity of the immune system. It is used to treat rheumatic conditions, such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis. Topical Tofacitinib is used for the Treatment of Vitiligo in adolescent patients. Since it is a JAK1 and JAK3 inhibitor that interferes with interferon-γ signaling, which reduces CXCL10 chemokine expression, this helps in blocking the activity of vitiligo.
Tofacitinib inhibits Janus kinases, a group of intracellular enzymes involved in signaling pathways that affect hematopoiesis and immune cell function. Tofacitinib is indicated for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis, or moderately-to-severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF( tumor necrosis factor) blockers.
Tofacitinib is not recommended to be used in combination with other biologic disease-modifying anti-rheumatic drugs (DMARDs) or potent immunosuppressive agents such as azathioprine or cyclosporine.
The inhibition of JAKs can simultaneously block the function of multiple cytokines. Therefore, JAK inhibitors are emerging as a new class of drugs, which in dermatology can either be used systemically as oral drugs or locally in topical formulations.
At the recent SEC meeting for Dermatology and Allergy, the expert panel reviewed the protocol for Phase III Clinical Trial of Tofacitinib Ointment 2% in detail.
After detailed deliberation, the committee recommended the grant of permission for conduct of Phase III clinical trial as per the protocol presented subject to the following conditions:
1) Post-trial access to a standard of care for the patients should be included in the clinical trial protocol for patient safety.
2) The firm should present the data of the first 50 patients (equally distributed in each arm) enrolled in the study for review by the committee, prior to further recruitment of the patients in the clinical trial.
3) More study sites from the government hospitals geographically distributed in the country should be included in the study.
In addition, the committee directed the firm to submit a revised clinical trial protocol to CDSCO.
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