A Phase 2 interventional study of INCA034176 and Best available Treatment (BAT) in Chronic Graft-versus-host-disease, sponsored by Incyte Corporation. Recruiting at 41 sites in 6 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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Among 10 studies testing axatilimab in Bronchiolitis Obliterans Syndrome — 5 open to participants now, 9 under way, 3 of them phase 3. axatilimab · Bronchiolitis Obliterans Syndrome.
Among the 10 studies testing axatilimab in Bronchiolitis Obliterans Syndrome, this one is the 4th largest by planned enrollment, is the only one that started in 2026, is one of 5 in phase 2, and was the 10th registered.
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
Browse Bronchiolitis Obliterans Syndrome studies →5 of the 10 studies testing axatilimab in Bronchiolitis Obliterans Syndrome are open now, in 12 countries. Recruiting first, the newest first:
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
University of Miami · Sites in United States
Ages 12+
Incyte Corporation · Sites in United States, Australia, Austria and 10 more countries
Ages 12+
Syndax Pharmaceuticals · Sites in United States, Australia, Belgium and 13 more countries
Ages 2+
By country, each count listing its studies:
axatilimab: first FDA approval 2024 (NIKTIMVO). What it is approved for, and how studies give it, is on its page →
Of the 100 Bronchiolitis Obliterans Syndrome studies recruiting now, 45 (45%) set no upper age limit and 45 (45%) stop at 75 or younger; 25 take children under 18; 12 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 7 · Phase 3 3
First in 2018; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Median enrollment 50 across the 10 interventional studies. Of the 1 that completed or were terminated, 1 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 10 have an industry lead sponsor. The 5 most frequent:
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.
12 studies in Bronchiolitis Obliterans Syndrome by Incyte Corporation: 4 open now, 8 under way, 4 of them phase 3. Of 4 finished, 3 (75%) have results posted.
Among the 12 studies in Bronchiolitis Obliterans Syndrome by Incyte Corporation, this one is the 6th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 3 in phase 2, and was the 12th registered.
Incyte Corporation’s Bronchiolitis Obliterans Syndrome studies by the year they started, since 2017.
2 of the studies testing axatilimab in Bronchiolitis Obliterans Syndrome that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585774Phase 3Incyte CorporationA Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease | 2027-09-28 |
| NCT06843408Incyte CorporationA Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD | 2027-01-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 10 studies testing axatilimab in Bronchiolitis Obliterans Syndrome, from their registry updates:
Among Incyte Corporation’s 12 in Bronchiolitis Obliterans Syndrome:
This tab as a report to print or save as PDF → With an account.
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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 at the protocol-defined dose.
Drug: INCA034176
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Drug: Best available Treatment (BAT)
Axatilimab at the protocol-defined dose.
Also known as: Axatilimab
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Also known as: BAT could include:, • Calcineurin inhibitor (cyclosporine or tacrolimus), • Extracorporeal photopheresis (ECP), • Mycophenolate mofetil (MMF), • A mammalian target of rapamycin (mTOR) inhibitor (everolimus or sirolimus), • Rituximab, • Imatinib, • Methotrexate, • Ibrutinib
Objective Response (OR) at 6 months
Defined as complete response (CR) or partial response (PR) at 6 months (Cycle 7 Day 1, 28-day cycles) in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.
Time frame: 6 months
United States (US): Best overall Response (BOR)
Defined as a best response of CR or PR in the first 6 months (up to and including Cycle 7 Day 1) in the absence of new systemic therapy for cGVHD.
Time frame: Up to 6 months
Pharmacokinetics Parameter (PK): Cmax of axatilimab
Defined as maximum observed plasma concentration of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: Tmax of axatilimab
Defined as the time to reach the maximum plasma concentration of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: Cmin of axatilimab
Defined as the minimum observed plasma concentration of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: AUC(0-t) of axatilimab
Defined as the area under the concentration-time curve up to the last measurable concentration of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: AUC 0-∞ of axatilimab
Defined as the area under the concentration-time curve from 0 to infinity of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: CL of axatilimab
Defined as the apparent oral dose clearance of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: Vz of axatilimab
Defined as the apparent oral dose volume of distribution of axatilimab.
Time frame: Up to 5 years
Pharmacokinetics Parameter: t1/2 of axatilimab
Defined as the apparent terminal phase disposition half-life of axatilimab.
Time frame: Up to 5 years
Best Overall Response (BOR) on study
Defined as a best response of CR or PR at any timepoint up to the initiation of new systemic therapy for cGVHD.
Time frame: Up to 5 years
BOR in the first 6 months
Defined as a best response of CR or PR in the first 6 months (up to and including Cyle 7 Day 1) in the absence of new systemic therapy for cGVHD.
Time frame: Up to 6 months
Overall Response (OR) at 12 months
Defined as CR or PR at 12 months (Cycle 13 Day 1) in the absence of new systemic therapy for cGVHD.
Time frame: 12 months
US: OR at 6 months
Defined as CR or PR at 6 months (Cycle 7 Day 1) in the absence of new systemic therapy for cGVHD.
Time frame: 6 months
Duration of Response (DOR) (in responders only)
Defined as the time from the date of first response (PR or CR) to the date of progression of cGVHD, initiation of new systemic treatment for cGVHD, or death from any cause, whichever comes first. An additional measure of response durability will consider DOR as the time from the date of first response to the date of new systemic therapy for cGVHD or death from any cause, whichever occurs first.
Time frame: Up to 5 years
Organ-specific response
Organ-specific response as defined in the protocol.
Time frame: Up to 5 years
Percent reduction in daily corticosteroid dose at 6 months
Defined as Percent reduction in daily corticosteroid dose at Cycle 7 Day 1, and participants successfully tapered off all corticosteroids at Cycle 7 Day 1.
Time frame: 6 months
Changes in parameters collected using the pediatric stem cell quality of life (Q0L) questionnaire (PedsQL Stem Cell Transplant Module)
Time frame: Up to 5 years
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 5 years and 30 days
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 May 2026 (actual). Primary completion is estimated for Jan 2029, 32 months after the start.
Of 63 phase 2 interventional studies under Bronchiolitis Obliterans Syndrome, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. 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 →