Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

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Brief Title

Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

Brief Summary

      The purpose of this study is to evaluate the efficacy and safety of parsclisib compared with
      placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
    

Detailed Description

      Prospective participants must have primary wAIHA as well as other protocol-defined criteria.
      After participants have been determined to be eligible for the study, they will be randomized
      to 1 of 2 treatment groups, with stratification for hemoglobin (Hgb <9 g/dL or ≥ 9 g/dL).
      Once a participant has completed the week 24 assessments, the participant will have the
      opportunity to crossover to begin receiving parsaclisib in the open-label treatment which
      will last up to another 24 weeks in duration.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of participants attaining a durable hemoglobin response

Secondary Outcome

 Proportion of participants with a ≥ 3-point increase in FACIT-F score

Condition

Warm Autoimmune Hemolytic Anemia (wAIHA)

Intervention

parsaclisinib

Study Arms / Comparison Groups

 Group A: Parsaclisib
Description:  Participants will receive parsaclisib for 24 weeks (double-blind period). Participant who completed the double-blind period and tolerating the study treatment upon investigator's opinion will continue into open-label extension period for an additional 24 weeks. starting from Day 1 for 24 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

November 12, 2021

Completion Date

June 4, 2024

Primary Completion Date

March 13, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of primary warm AIHA.

          -  Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to
             receive or tolerate other therapies.

          -  Hemoglobin ≥ 7 to < 10 g/dL with symptoms of anemia at screening.

          -  FACIT-F score ≤ 43 at screening.

          -  Willingness to avoid pregnancy or fathering children.

          -  Willingness to receive PJP prophylaxis.

          -  Further inclusion criteria apply.

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding or who are planning a pregnancy.

          -  Diagnosis of other types of AIHA (CAD, cold agglutinin syndrome, mixed-type AIHA or
             paroxysmal cold hemoglobinuria).

          -  Secondary warm AIHA from any cause.

          -  Splenectomy less than 3 months before randomization.

          -  Participants with a history or ongoing significant illness as assessed by the
             investigator.

          -  Participants with a current of medical history of a malignancy within the past 5 years
             except basal or squamous cell skin cancer that has been removed and considered cured,
             or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of
             the cervix, or other noninvasive or indolent malignancy.

          -  Participants know to be infected with HIV, Hepatitis B, or hepatitis C.

          -  Chronic or current active infectious disease requiring systemic antibiotics,
             antifungal, or antiviral treatment or exposure to a live vaccine.

          -  Participants with laboratory values outside of the protocol defined ranges.

          -  Further exclusion criteria apply.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Kathleen Butler, MD, 1.855.463.3463, [email protected]



Administrative Informations


NCT ID

NCT05073458

Organization ID

INCB 50465-309


Responsible Party

Sponsor

Study Sponsor

Incyte Corporation


Study Sponsor

Kathleen Butler, MD, Study Director, Incyte Corporation


Verification Date

October 2021