Trial intelligence / Profile preview

Parsaclisib in Autoimmune Hemolytic Anemia

NCT03538041Phase 2

Key facts

Status: Completed
Start: Nov 2018
Primary completion: Aug 2021
Countries: 4
Sponsor: Incyte
Modality: Small Molecules

Drugs: parsaclisib
Conditions: autoimmune hemolytic anemia (AIHA)

Overview

Phase 2, open-label trial of parsaclisib in autoimmune hemolytic anemia (AIHA) (2 arms), sponsored by Incyte. Primary endpoints: Percentage of Participants Attaining a Complete Response, Percentage of Participants Attaining a Partial Response and 1 more. Started Nov 2018; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Parsaclisib 1 mg QD
Parsaclisib 1 mg daily
Parsaclisib 2.5 mg QD
Parsaclisib 2.5 mg daily

Who it enrols

Adult patients with diagnosed AIHA (hemolytic anemia + positive DAT) who have progressed on, are intolerant to, or refused standard therapies, with Hb 7-10 g/dL.

Endpoints

Primary

Percentage of Participants Attaining a Complete ResponseWeek 6 to Week 12
Percentage of Participants Attaining a Partial ResponseWeek 6 to Week 12
Number of Participants With Any Treatment-emergent Adverse Eventup to 1638 days

Secondary

Percentage of Participants Attaining a Complete Response During Post-Baseline Visitsup to 1638 days
Percentage of Participants Attaining a Partial Response During Post-Baseline Visitsup to 1638 days
Percentage of Participants Attaining a >= 2 g/dL Increase in Hemoglobin From Baselineup to 1638 days
Change From Baseline in Hemoglobinup to 1638 days
Percentage of Participants Requiring Transfusionsup to 1638 days
Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, LDH, Reticulocyte Count, and Bilirubinup to 1638 days
Percentage of Participants Requiring a Prednisone Dose Changeup to 1638 days
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Subscale Scoresup to 1638 days

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