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

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    100
  • sponsor
    Incyte Corporation
Updated on 4 October 2022

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),

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.

Details
Condition Warm Autoimmune Hemolytic Anemia (wAIHA)
Treatment Placebo, parsaclisinib
Clinical Study IdentifierNCT05073458
SponsorIncyte Corporation
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note