Immune ThrombocytopeniaPhase 2NCT07104565
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
A Phase 2 study testing INCA000585 in people with Immune Thrombocytopenia, run by Incyte Corporation at 39 sites in 7 countries.
Trial summary
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- INCA000585
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 39 sitesin 7 countries
- Study dates
- 29 Dec 2025to 9 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged ≥ 18 years.
- Confirmed historical diagnosis of one of the following autoimmune blood disorders:
- Primary ITP.
- Primary wAIHA.
- No history of splenectomy.
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- Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab):
- Primary ITP: Increase in platelet count to ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count.
- Primary wAIHA: Increase in hemoglobin to ≥ 10 g/dL with an increase of at least 2 g/dL from baseline.
- Received ≥ 1 standard course of rituximab (375 mg/kg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible.
- Primary ITP: a PR (platelet count ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count > 100 × 109/L) lasting < 48 weeks OR NR (platelet count < 30 × 109/L or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose.
- Primary wAIHA: a PR with hemoglobin ≥ 10 g/dL and with an increase of at least 2 g/dL from baseline OR a CR (hemoglobin ≥ 12 g/dL and normalization of hemolytic markers) OR NR (hemoglobin < 10 g/dL or < 2 g/dL increase of baseline hemoglobin).
- Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion.
- Primary ITP: platelet count < 30 × 109/L within the 15 days before treatment is scheduled to begin (Day 1).
- Note: Participants treated with a rescue therapy during screening in response to a documented platelet count < 30 × 109/L are eligible, irrespective of platelet count within 15 days of Day 1.
- Primary wAIHA: hemoglobin < 10 g/dL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and/or indirect bilirubin.
- ECOG performance status of 0 to 2.
- Willingness to avoid pregnancy or fathering children.
- Further inclusion criteria apply.
Who cannot join
- Clinical manifestations typical for cold agglutinin disease.
- Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin < 6 g/dL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.
- Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.
- Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab.
- Changes in doses (> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.
- Evidence of hypogammaglobulinemia during screening (IgA < 70 mg/dL, IgG < 700 mg/dL, and/or IgM < 40 mg/dL) and frequent and/or severe infections.
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- Women who are pregnant or breastfeeding.
- History of malignancy except for the following:
- Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening.
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
- Congestive heart failure (left ventricular ejection fraction of < 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan).
- Participants with:
- Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA.
- Note: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result.
- Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result).
- Note: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines.
- Note: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible.
- Seropositivity for or history of active viral infection with HIV.
- Active systemic infection (including infection with SARS-CoV-2).
- Participants in a severely immunocompromised state, per investigator's clinical assessment.
- Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable).
- Coagulation or platelet function abnormality.
- An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months).
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment/enrollment (except for chronic toxicities [≤ Grade 2] not expected to resolve).
- Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications.
- Unwillingness to undergo transfusion with blood components.
- Current use of prohibited medication as described in the protocol.
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Further exclusion criteria apply.
Trial locations and contacts
39 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 7 countries
United States9 sites, 9 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Gnp Research
Cooper City, Florida, 33024
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Recruiting
Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale
Glendale, Arizona, 85304
- Recruiting
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
- Recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna
Bologna, 40138
- Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari)
Brescia, 25123
- Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola, 47013
- Recruiting
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Azienda Ospedaliera Universitaria Federico Ii
Naples, 80131
- Recruiting
Azienda Ospedale Universita Di Padova
Padova, 35128
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 00136
France7 sites, 7 recruiting
- Recruiting
Chu Angers - Hôpital Hôtel Dieu
Angers, 49933
- Recruiting
Chu Caen - Hôpital de La Côte de Nacre
Caen, 14033
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
- Recruiting
Chu Dijon - Hopital Du Bocage
Dijon, 21079
- Recruiting
Chu Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
- Recruiting
Hopital Purpan
Toulouse, 31059
- Recruiting
Chru de Nancy- Hopital de Brabois
Vandœuvre-lès-Nancy, 54500
Australia6 sites, 6 recruiting
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 03128
- Recruiting
Monash Medical Centre Clayton
Clayton, Victoria, 03168
- Recruiting
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales, 02010
- Recruiting
Townsville University Hospital
Douglas, Queensland, 04814
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 03004
- Recruiting
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam Umc, Locatie Vumc
Amsterdam, 1105 AZ
- Recruiting
Radboudumc
Nijmegen, 6500 HB
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
United Kingdom3 sites, 3 recruiting
- Recruiting
Castle Hill Hospital
Cottingham, HU16 5JQ
- Recruiting
Barts Hospital
London, E1 2ES
- Recruiting
Plymouth Hospitals Nhs Trust
Plymouth, PL6 8DH
Spain2 sites, 2 recruiting
- Recruiting
Ico Badalona. Hospital Universitario Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
About this study
Official title: A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
- Conditions
- Immune Thrombocytopenia
- Being tested
- INCA000585
- Keywords
- primary warm autoimmune hemolytic anemia, primary immune thrombocytopenia, anti-CD19 monoclonal antibody
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA000585Drug
Tafasitamab will be administered intravenously at protocol defined timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - primary immune thrombocytopenia (ITP) | Experimental | INCA000585 will be administered intravenously. Receives: Drug: INCA000585 |
| Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) | Experimental | INCA000585 will be administered intravenously. Receives: Drug: INCA000585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Measured: Up to 52 weeks
Stable platelet response
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Measured: After Day 56 up to Week 48
Stable hemoglobin response
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
Measured: After Day 56 up to Week 48
Secondary outcomes (14)
Complete Response (CR)
Defined as platelet count ≥ 100 × 109/L at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Measured: Week 24
CR (complete remission)
Defined as platelet count ≥ 100 × 109/L at Week 48 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Measured: Week 48
Partial Response (PR)
Defined as platelet count ≥ 30 × 109/L and at least a 2-fold increase of baseline platelet count at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Measured: Week 24
Duration of stable platelet response
Defined as time from start of stable platelet response to loss of platelet response (< 50 × 109/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Measured: Up to Week 48
Duration of CR
Defined as time from the start of CR to loss of CR (platelet count < 100 × 109/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Measured: Up to Week 48
Duration of response
Defined as time from the date of the first response (PR or CR) to the loss of response (platelet count < 30 × 109/L or a less than a 2-fold increase of baseline platelet count), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Measured: Up to Week 48
CR
Defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 24 in the absence of rescue therapy in participants with primary wAIHA.
Measured: Week 24
CR (Complete remission)
Defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 48 in the absence of rescue therapy in participants with primary wAIHA.
Measured: Week 48
PR
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline at Week 24 in the absence of rescue therapy in participants with primary wAIHA.
Measured: Week 24
Duration of stable hemoglobin response
Defined as time from start of stable hemoglobin response to loss of stable hemoglobin response (< 10 g/dL or a < 2 g/dL increase from baseline), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Measured: Up to Week 48
Duration of CR
Defined as time from start of CR to loss of CR (hemoglobin < 12 g/dL or abnormal hemolytic markers [unconjugated bilirubin, LDH, haptoglobin, and reticulocytes]), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Measured: Up to Week 48
Duration of response
Defined as time from the date of the first response (PR or CR) to the loss of response (hemoglobin < 10 g/dL), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Measured: Up to Week 48
Serum concentrations of tafasitamab
Serum concentrations of tafasitamab at each assessed timepoint.
Measured: Up to Week 48
Change from baseline in serum antidrug antibody levels
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start29 Dec 2025
- Primary completion23 Sep 2027 (estimated)
- Study completion9 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104565
- Sponsor's protocol ID
- INCA000585-201
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
- ClinicalTrials.gov ID
- NCT07104565
- Acronym / sponsor ID
- INCA000585-201
- Conditions
- Immune Thrombocytopenia
- Keywords
- primary warm autoimmune hemolytic anemia, primary immune thrombocytopenia, anti-CD19 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 23 Sep 2027 (estimated)
- Study completion
- 9 Mar 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - primary immune thrombocytopenia (ITP) | Experimental | Drug: INCA000585INCA000585 will be administered intravenously. |
| Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) | Experimental | Drug: INCA000585INCA000585 will be administered intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged ≥ 18 years.
- Confirmed historical diagnosis of one of the following autoimmune blood disorders:
- No history of splenectomy.
- Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab):
Key exclusion criteria (31 listed)
- Clinical manifestations typical for cold agglutinin disease.
- Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin < 6 g/dL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.
- Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.
- Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab.
- Changes in doses (> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.
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 |
|---|---|---|
| INCA000585Tafasitamab will be administered intravenously at protocol defined timepoints. | Drug | Cohort 1 - primary immune thrombocytopenia (ITP), Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) |
Primary outcome
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 52 weeks
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Stable platelet response
Time frame: After Day 56 up to Week 48
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Stable hemoglobin response
Time frame: After Day 56 up to Week 48
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
14 secondary outcomes
Complete Response (CR)
Time frame: Week 24
CR (complete remission)
Time frame: Week 48
Partial Response (PR)
Time frame: Week 24
Duration of stable platelet response
Time frame: Up to Week 48
Duration of CR
Time frame: Up to Week 48
Duration of response
Time frame: Up to Week 48
CR
Time frame: Week 24
CR (Complete remission)
Time frame: Week 48
PR
Time frame: Week 24
Duration of stable hemoglobin response
Time frame: Up to Week 48
Duration of CR
Time frame: Up to Week 48
Duration of response
Time frame: Up to Week 48
Serum concentrations of tafasitamab
Time frame: Up to Week 48
Change from baseline in serum antidrug antibody levels
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell DisordersLink provided by the sponsor.
- 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
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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.
Incyte Medical Monitor study director
Incyte Corporation
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCA000585 in people with Immune Thrombocytopenia, run by Incyte Corporation at 39 sites in 7 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 19 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Italy, France, Australia, Netherlands and 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 52 weeks). The study lists 3 primary outcomes in all. 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 30 Oct 2026.