Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA034176 · 5 trials · 1 indication
Defined for each treatment group 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.
Defined from the date of randomization to the date of any predefined event, whichever occurs first.
The overall response rate will be assessed by the number of participants with objective response by Cycle 7 (28-day cycles), Day 1, with responses defined by the 2014 NIH consensus criteria.
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.
Defined as adverse events reported for the first time or worsening of a pre-existing event, occurring after the first dose.
The overall response rate will be assessed by the number of participants with objective response by Cycle 7 (28-day cycles), Day 1, with responses defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
| Arm | Type | Description |
|---|---|---|
| Axatilimab | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Best available Treatment (BAT) | EXPERIMENTAL | 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. |
| Axatilimab + Corticosteroids | EXPERIMENTAL | Axatilimab and Corticosteroids at the protocol-defined dose. |
| Placebo + Corticosteroids | EXPERIMENTAL | Matching placebo and Corticosteroids at the protocol-defined dose. |
| Axatilimab Dose | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Part 1 Safety Evaluation | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Part 2 Efficacy Evaluation | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Name | Type | Description |
|---|---|---|
| INCA034176 | DRUG | IV infusion |
| Best Available Therapy (BAT) | DRUG | 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. |
| Placebo | DRUG | IV infusion |
| Corticosteroids | DRUG | Oral/IV Infusion |
| Best available Treatment (BAT) | DRUG | 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. |
Inclusion Criteria: * Age ≥ 12 years at the time of signing the ICF. * Active, moderate to severe cGVHD, requiring systemic immune suppression. * Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * Conc...
INCA034176 is an investigational small molecule being developed by Incyte Corporation for the treatment of chronic graft-versus-host disease (cGVHD). It is currently in Phase 3 clinical development and is being studied in patients with recurrent or refractory active chronic graft-versus-host disease.
INCA034176 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The drug is currently in Phase 3 clinical trials for chronic graft-versus-host disease.
INCA034176 is in Phase 3 clinical development for chronic graft-versus-host disease. It is an investigational drug and has not been approved by regulatory authorities. The company is conducting multiple trials to evaluate its efficacy and safety in this indication.
INCA034176 is being studied in five clinical trials, including NCT06263478, a Phase 3 study in Japanese participants with recurrent or refractory active chronic graft-versus-host disease, and NCT06821542, a Phase 3 study comparing it to best available therapy in patients with cGVHD after at least two prior lines of systemic therapy.
Yes, INCA034176 is also known as axatilimab. Clinical trials listed under the name axatilimab, such as NCT06263478 and NCT06821542, are evaluating this drug for chronic graft-versus-host disease. The drug is being developed by Incyte Corporation.
The clinical trials for INCA034176 have a total planned enrollment of 362 participants across five studies. All trials are active, with four not recruiting and one actively recruiting participants. The trials are randomized, double-blind, and controlled.