Intas Pharmaceutical Gets CDSCO Panels Nod to Conduct Phase III clinical trial of Ruxolitinib cream
New Delhi: Intas Pharmaceutical has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase-III clinical trial of Ruxolitinib cream 1.5% w/w subject to condition that the firm should submit revised clinical trial protocol by incorporating the details of study centers in which the study would be conducted.
In addition to the above, the expert panel stated that 50% sites should be from government hospitals and protocol should uniformly include participants aged ≥ 18 years instead of ≥ 12 years in the inclusion criteria to CDSCO.
Furthermore, the committee added, "As this is an equivalence study, the document detailing the need for the study and the study design of protocol submitted to CDSCO should also be submitted for review."
This came after the firm presented its proposal for a grant of permission to conduct a Phase III clinical trial of Ruxolitinib cream 1.5% w/w along with phase-III clinical trial protocol before the committee.
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK Inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.
Ruxolitinib is a kinase inhibitor used to treat various types of myelofibrosis and polycythemia vera in patients who have not responded to or cannot tolerate hydroxyurea and to treat graft-versus-host disease in cases that are refractory to steroid treatment.
At the recent SEC meeting for dermatology and allergy held on October 8, 2024, the expert panel reviewed the proposal for a grant of permission to conduct a phase-III clinical trial of Ruxolitinib cream 1.5% w/w.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase-III clinical trial of Ruxolitinib cream 1.5% w/w subject to the condition that the firm should submit revised clinical trial protocol by incorporating the details of study centers in which the study would be conducted and 50% sites should be from government hospitals and protocol should uniformly include participants aged ≥ 18 years instead of ≥ 12 years in the inclusion criteria to CDSCO.
As this is an equivalence study, the document detailing the need for the study and the study design of protocol submitted to CDSCO should also be submitted for review.
