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Promising drug for rare blood disorder trial halted early

NCT ID NCT05073458

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested the drug parsaclisib in people with primary warm autoimmune hemolytic anemia, a condition where the immune system destroys red blood cells. The trial aimed to see if parsaclisib could improve hemoglobin levels and reduce fatigue compared to a placebo. However, the study was terminated early after enrolling only 13 participants, so the results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
parsaclisib
What this could lead to
If successful, parsaclisib could offer a new treatment option for people with warm autoimmune hemolytic anemia who have not responded to other therapies.
What could go wrong
The trial was terminated early with only 13 participants, so results are limited. It is unclear if parsaclisib is effective or safe for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

13 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 ≥ 6.5 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 or diagnosis of Evans syndrome. * 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.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Warm autoimmune hemolytic anemia (waiha)

Contacts and locations

Locations

  • Investigative Site AT001

    Vienna, 01090, Austria

  • Investigative Site AT002

    Salzburg CET, A-5020, Austria

  • Investigative Site BE001

    La Louvière, 07100, Belgium

  • Investigative Site BE002

    Liège, 04000, Belgium

  • Investigative Site CA001

    Edmonton, Alberta, T6G 2P4, Canada

  • Investigative Site DE001

    Essen, 45147, Germany

  • Investigative Site DE002

    Ulm, 89081, Germany

  • Investigative Site ES001

    Barcelona, 08036, Spain

  • Investigative Site ES002

    Valencia, 46026, Spain

  • Investigative Site ES003

    Madrid, 28006, Spain

  • Investigative Site ES004

    Tarragona, 43005, Spain

  • Investigative Site ES005

    Murcia, 30008, Spain

  • Investigative Site ES006

    Badalona, 08916, Spain

  • Investigative Site FR001

    Paris, 75015, France

  • Investigative Site FR002

    Lille, 59037, France

  • Investigative Site FR003

    Marseille, 13285, France

  • Investigative Site GB002

    Glasgow, G4 0SF, United Kingdom

  • Investigative Site GB003

    Norwich, NR4 7UY, United Kingdom

  • Investigative Site GB004

    Plymouth, PL6 8DH, United Kingdom

  • Investigative Site GB005

    Reading, RG1 5AN, United Kingdom

  • Investigative Site GB006

    London, W12 0HS, United Kingdom

  • Investigative Site IL001

    Nahariya, 2210001, Israel

  • Investigative Site IL002

    Haifa, 31096, Israel

  • Investigative Site IT001

    Novara, 28100, Italy

  • Investigative Site IT002

    Milan, 20122, Italy

  • Investigative Site IT003

    Florence, 50134, Italy

  • Investigative Site IT004

    Pavia, 27100, Italy

  • Investigative Site IT005

    Trieste, 34125, Italy

  • Investigative Site IT006

    Rome, 00168, Italy

  • Investigative Site JP001

    Suita-shi, 565-0871, Japan

  • Investigative Site JP002

    Okayama, 701-0192, Japan

  • Investigative Site JP003

    Tokyo, 141-8625, Japan

  • Investigative Site JP004

    Isehara, 259-1193, Japan

  • Investigative Site JP005

    Saitama, 350-0495, Japan

  • Investigative Site JP006

    Nagoya, 467-8602, Japan

  • Investigative Site JP007

    Sendai, 980-8574, Japan

  • Investigative Site JP008

    Fukuoka, 807-8556, Japan

  • Investigative Site JP009

    Okayama, 700-8557, Japan

  • Investigative Site JP010

    Osakasayama-shi, 589-8511, Japan

  • Investigative Site NL001

    Rotterdam, 3015CA, Netherlands

  • Investigative Site PL001

    Legnica, 59220, Poland

  • Investigative Site PL002

    Wroclaw, 53-439, Poland

  • Investigative Site PL003

    Nowy Sącz, 33-300, Poland

  • Investigative Site PL004

    Wałbrzych, 58-309, Poland

  • Investigative Site PL005

    Opole, 45-372, Poland

  • Investigative Site PL006

    Lodz, 93-510, Poland

  • Investigative Site US001

    Knoxville, Tennessee, 37920, United States

  • Investigative Site US002

    The Bronx, New York, 10467, United States

  • Investigative Site US003

    Greenville, North Carolina, 27858, United States

  • Investigative Site US004

    Whittier, California, 90603, United States

  • Investigative Site US005

    Los Angeles, California, 90089, United States

  • Investigative Site US006

    Miami, Florida, 33165, United States

  • Investigative Site US007

    The Bronx, New York, 10461, United States

  • Investigative Site US009

    Canton, Ohio, 44718, United States

  • Investigative Site US010

    Easton, Pennsylvania, 18045, United States

  • Investigative Site US012

    Indianapolis, Indiana, 46260, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.