A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms

The primary objective of this phase 1 study is to evaluate the safety and tolerability of INCB160058 in individuals diagnosed with myeloproliferative neoplasms. Assessing these parameters is essential for determining the initial clinical profile and establishing acceptable dosing regimens for this investigational agent.

The study involves a total of 100 patients diagnosed with myeloproliferative neoplasms. The study population includes both males and females within the age range of 3 to 5 years. This group is identified as a vulnerable population. The sponsor did not provide information regarding selection methods, lifestyle considerations, or specific inclusion and exclusion criteria.

This is a Phase 1, open-label, multicenter study evaluating the effects of INCB160058 in individuals diagnosed with myeloproliferative neoplasms. The study design involves a sequence of clinical assessments beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor physiological responses and safety profiles, concluding with an end-of-study visit. The total duration of participant involvement is determined by the prescribed clinical schedule. Conditions leading to early termination from the study may include deviations from the protocol or safety concerns as identified by clinical investigators.

The clinical trial aims to evaluate the efficacy of the investigational intervention in patients diagnosed with myeloproliferative neoplasms. The assessment of therapeutic efficacy is conducted within the framework of a phase 3 study.