Warm Autoimmune Hemolytic Anemia (wAIHA)Phase 3PATHWAYNCT05073458
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
A Phase 3 study testing parsaclisinib in people with Warm Autoimmune Hemolytic Anemia (wAIHA), run by Incyte Corporation at 56 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA), Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- What is being tested?
- parsaclisinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 56 sitesin 13 countries
- Study dates
- 15 Mar 2022to 29 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
56 sites in 13 countries.
56 sites in 13 countries
United States10 sites
Investigative Site US009
Canton, Ohio, 44718
Investigative Site US010
Easton, Pennsylvania, 18045
Investigative Site US003
Greenville, North Carolina, 27858
Investigative Site US012
Indianapolis, Indiana, 46260
Investigative Site US001
Knoxville, Tennessee, 37920
Investigative Site US005
Los Angeles, California, 90089
Investigative Site US006
Miami, Florida, 33165
Investigative Site US007
The Bronx, New York, 10461
Investigative Site US002
The Bronx, New York, 10467
Investigative Site US004
Whittier, California, 90603
Japan10 sites
Investigative Site JP008
Fukuoka, 807-8556
Investigative Site JP004
Isehara, 259-1193
Investigative Site JP006
Nagoya, 467-8602
Investigative Site JP009
Okayama, 700-8557
Investigative Site JP002
Okayama, 701-0192
Investigative Site JP010
Osakasayama-shi, 589-8511
Investigative Site JP005
Saitama, 350-0495
Investigative Site JP007
Sendai, 980-8574
Investigative Site JP001
Suita-shi, 565-0871
Investigative Site JP003
Tokyo, 141-8625
Italy6 sites
Investigative Site IT003
Florence, 50134
Investigative Site IT002
Milan, 20122
Investigative Site IT001
Novara, 28100
Investigative Site IT004
Pavia, 27100
Investigative Site IT006
Rome, 00168
Investigative Site IT005
Trieste, 34125
Poland6 sites
Investigative Site PL001
Legnica, 59220
Investigative Site PL006
Lodz, 93-510
Investigative Site PL003
Nowy Sącz, 33-300
Investigative Site PL005
Opole, 45-372
Investigative Site PL004
Wałbrzych, 58-309
Investigative Site PL002
Wroclaw, 53-439
Spain6 sites
Investigative Site ES006
Badalona, 08916
Investigative Site ES001
Barcelona, 08036
Investigative Site ES003
Madrid, 28006
Investigative Site ES005
Murcia, 30008
Investigative Site ES004
Tarragona, 43005
Investigative Site ES002
Valencia, 46026
United Kingdom5 sites
Investigative Site GB002
Glasgow, G4 0SF
Investigative Site GB006
London, W12 0HS
Investigative Site GB003
Norwich, NR4 7UY
Investigative Site GB004
Plymouth, PL6 8DH
Investigative Site GB005
Reading, RG1 5AN
France3 sites
Investigative Site FR002
Lille, 59037
Investigative Site FR003
Marseille, 13285
Investigative Site FR001
Paris, 75015
Austria2 sites
Investigative Site AT002
Salzburg CET, A-5020
Investigative Site AT001
Vienna, 01090
Belgium2 sites
Investigative Site BE001
La Louvière, 07100
Investigative Site BE002
Liège, 04000
Germany2 sites
Investigative Site DE001
Essen, 45147
Investigative Site DE002
Ulm, 89081
Israel2 sites
Investigative Site IL002
Haifa, 31096
Investigative Site IL001
Nahariya, 2210001
About this study
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
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
Read the 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 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb <9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.
- Conditions
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Being tested
- parsaclisinib, placebo
- Keywords
- Warm Autoimmune Hemolytic Anemia (wAIHA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parsaclisinibDrug
Also called INCB050465
parsaclisib will be administered QD orally
placeboDrug
placebo will be administered QD orally follwed by Parsaclisinib in the open label period
| Study group | Role | What they receive |
|---|---|---|
| Group A: Parsaclisib | Experimental | 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 period for an additional 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period. Receives: Drug: parsaclisinib |
| Group B: Placebo followed by Parsaclisib | Placebo comparator | Participants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive parsaclisib in the 24 week open-label period. Participants may then continue to receive parsaclisib in a long-term extension period. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Attaining a Durable Hemoglobin Response
A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.
Measured: up to Week 24
Secondary outcomes (12)
Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 24
Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT)
The 6MWT is used to evaluate submaximal exercise capacity. It is a self-paced measurement of the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: Baseline; Week 24
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.
Measured: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Percentage change from Baseline was calculated as ([the post-Baseline value minus the Baseline value]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.
Measured: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.
Measured: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Percentage change from Baseline was calculated as ([the post-Baseline value minus the Baseline value]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.
Measured: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56
Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48
Transfusion was permitted as a rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a > 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of warm autoimmune hemolytic anemia (wAIHA).
Measured: Week 6 to Week 24; Week 24 to Week 48
Change From Baseline in Daily Corticosteroid Dose at Week 24
A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a > 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 24
Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24
A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a > 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Percentage change from Baseline was calculated as ([the post-Baseline value minus the Baseline value]/Baseline value) x 100.
Measured: Baseline; Week 24
Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48
Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a > 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA.
Measured: Week 6 to Week 24; Week 24 to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug.
Measured: up to 446 days
Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to 446 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Mar 2022
- Primary completion17 Oct 2023
- Study completion29 Apr 2024
Why it stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Warm Autoimmune Hemolytic Anemia (wAIHA)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Butler, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073458
- Sponsor's protocol ID
- INCB 50465-309
- Other IDs
- 2021-002844-66
- Acronym
- PATHWAY
- Status last verified
- Oct 2025
- First submitted
- 28 Sep 2021
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05073458
- Acronym / sponsor ID
- PATHWAY / INCB 50465-309
- Conditions
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Keywords
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of parsaclisib 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 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb <9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Parsaclisib | Experimental | Drug: parsaclisinibParticipants 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 period for an additional 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period. |
| Group B: Placebo followed by Parsaclisib | Placebo comparator | Drug: placeboParticipants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive parsaclisib in the 24 week open-label period. Participants may then continue to receive parsaclisib in a long-term extension period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parsaclisinibAlso: INCB050465parsaclisib will be administered QD orally | Drug | Group A: Parsaclisib |
| placeboplacebo will be administered QD orally follwed by Parsaclisinib in the open label period | Drug | Group B: Placebo followed by Parsaclisib |
Primary outcome
Percentage of Participants Attaining a Durable Hemoglobin Response
Time frame: up to Week 24
A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.
12 secondary outcomes
Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24
Time frame: Baseline; Week 24
Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT)
Time frame: Baseline; Week 24
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Time frame: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Time frame: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Time frame: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Time frame: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56
Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48
Time frame: Week 6 to Week 24; Week 24 to Week 48
Change From Baseline in Daily Corticosteroid Dose at Week 24
Time frame: Baseline; Week 24
Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24
Time frame: Baseline; Week 24
Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48
Time frame: Week 6 to Week 24; Week 24 to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 446 days
Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to 446 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Related trials for Warm Autoimmune Hemolytic Anemia (wAIHA)
RecruitingPhase 1/2
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
RecruitingPhase 3
A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
Autoimmune Haemolytic Anaemia
Active, not recruitingPhase 3
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia (wAIHA)
Active, not recruitingPhase 2/3
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Not yet recruitingPhase 1/2
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Butler, MD study director
Incyte Corporation
56 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing parsaclisinib in people with Warm Autoimmune Hemolytic Anemia (wAIHA), run by Incyte Corporation at 56 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Japan, Italy, Poland, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Attaining a Durable Hemoglobin Response (time frame: up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.