INCA34176-254: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
- Conditions
- chronic graft-versus-host disease
- Registration Number
- 2022-502168-19-00
- Lead Sponsor
- Incyte Corp.
- Brief Summary
The primary objective is to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 70
- At least 12 years of age at the time of informed consent. Note: Participants aged 12 to ˂ 18 years will not be enrolled in Germany, Italy, and the UK.
New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Criteria
History of 1 allo-SCT
Willingness to avoid pregnancy or fathering children
Participants who received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
- Has overlap cGVHD, defined as the presence of features or characteristics of aGVHD with simultaneous diagnostic and/or distinctive features of cGVHD.
Prior systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication, except for physiological replacement doses of corticosteroids (ie, < 10 mg/day prednisone equivalent) for adrenal insufficiency.
Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
Prior treatment with a JAK inhibitor within 8 weeks before randomization
Pregnant or breastfeeding
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria
- Secondary Outcome Measures
Name Time Method Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments. Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments.
DOR (in responders only) DOR (in responders only)
Proportion of participants with ≥ 7-point improvement in mLSS total score. Proportion of participants with ≥ 7-point improvement in mLSS total score.
Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria
OR at 12 months, defined as CR or PR at 12 months OR at 12 months, defined as CR or PR at 12 months
PK parameters for axatilimab and ruxolitinib PK parameters for axatilimab and ruxolitinib
• EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first. • EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first.
Trial Locations
- Locations (32)
University Clinical Hospital Virgen De La Arrixaca
🇪🇸Murcia, Spain
University Hospital Virgen Del Rocio S.L.
🇪🇸Sevilla, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital Universitario Marques De Valdecilla
🇪🇸Santander, Spain
Hospital Clinico Universitario De Valencia
🇪🇸Valencia, Spain
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Virgen De Las Nieves
🇪🇸Granada, Spain
Hospital Universitario Regional De Malaga
🇪🇸Malaga, Spain
Institut Catala D'oncologia
🇪🇸L'hospitalet De Llobregat, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Scroll for more (22 remaining)University Clinical Hospital Virgen De La Arrixaca🇪🇸Murcia, SpainAndres SanchezSite contact+34968369382asanchez2005@gmail.com