A Phase 3 interventional study of INCA034176 and Placebo in Chronic Graft-versus-host-disease, sponsored by Incyte Corporation. Recruiting at 131 sites in 13 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
This study's planned enrollment of 240 is above the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Axatilimab and Corticosteroids at the protocol-defined dose.
Drug: INCA034176 · Drug: Corticosteroids
Matching placebo and Corticosteroids at the protocol-defined dose.
Drug: Placebo · Drug: Corticosteroids
IV infusion
Also known as: Axatilimab
IV infusion
Oral/IV Infusion
Also known as: prednisone, methylprednisolone, prednisolone
Event Free Survival (EFS)
Defined from the date of randomization to the date of any predefined event, whichever occurs first.
Time frame: Up to 3 years
Objective Response (OR)
Defined for each treatment group as CR or PR at 6 months Cycle 7 (28-day cycles), Day 1, in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.
Time frame: 6 months
Event Free Survival 2
Defined from the date of randomization to the date of any predefined event, whichever occurs first.
Time frame: Up to 3 years
Proportion of participants with a ≥ 7-point improvement in mLSS total score
Time frame: Up to 3 years
Overall Response
Defined as CR or PR at 12 months in the absence of new systemic therapy for cGVHD.
Time frame: 12 Months
DOR (in responders only)
Defined as the time from the date of first response (PR or CR) to the date of progression of cGVHD from nadir in any organ, start of new systemic treatment for cGVHD, or death from any cause, whichever comes first.
Time frame: Up to 3 years
Best Overall Response (BOR)
Defined as the best response of CR or PR at any timepoint up to the initiation of new therapy for cGVHD.
Time frame: Up to 3 years
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to 3 years
Nonrelapse mortality (NRM)
Defined as the time from the date of randomization to the date of death in the absence of primary hematologic disease relapse.
Time frame: Up to 3 years
Failure-free survival (FFS)
Defined as the time from the date of randomization to the date of addition or initiation of another systemic therapy for cGVHD, relapse of underlying disease, or death due to any cause.
Time frame: Up to 3 years
Relapse of hematologic diseases
Defined as the reappearance of symptoms of underlying disease.
Time frame: Up to 3 years
Time to primary hematologic disease relapse
Defined as the time from the date of randomization to the date of relapse.
Time frame: Up to 3 years
Percent reduction in daily corticosteroid dose
Time frame: 6 months
Proportion of participants who tapered off all corticosteroids
Time frame: 6 months
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Up to 3 years and 30 days
Change from baseline in circulating monocyte number and phenotype (CD14/16)
Time frame: Up to 3 years and 30 days
Change from baseline in soluble markers for bone resorption and formation, including bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide (CTX)
Time frame: Up to 3 years and 30 days
Showing the first 100 of 131 sites across 13 countries. Choose a country and city above to see the rest.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Data sharing details ↗ · www.incyte.com
Started Jan 2025 (actual). Primary completion is estimated for Sep 2027, 32 months after the start.
Of 30 phase 3 interventional studies under Bronchiolitis Obliterans Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 62. This study's planned 32 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Axatilimab
Bronchiolitis Obliterans Syndrome →