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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06585774




Registration number
NCT06585774
Ethics application status
Date submitted
30/08/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Secondary ID [1] 0 0
2023-510292-65-00
Secondary ID [2] 0 0
INCA34176-357
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Graft-versus-host-disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCA034176
Treatment: Drugs - Placebo
Treatment: Drugs - Corticosteroids

Experimental: Axatilimab + Corticosteroids - Axatilimab and Corticosteroids at the protocol-defined dose.

Experimental: Placebo + Corticosteroids - Matching placebo and Corticosteroids at the protocol-defined dose.


Treatment: Drugs: INCA034176
IV infusion

Treatment: Drugs: Placebo
IV infusion

Treatment: Drugs: Corticosteroids
Oral/IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival (EFS)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Objective Response (OR)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Event Free Survival 2
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Proportion of participants with a = 7-point improvement in mLSS total score
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Overall Response
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
DOR (in responders only)
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Best Overall Response (BOR)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Nonrelapse mortality (NRM)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Failure-free survival (FFS)
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Relapse of hematologic diseases
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
Time to primary hematologic disease relapse
Timepoint [11] 0 0
Up to 3 years
Secondary outcome [12] 0 0
Percent reduction in daily corticosteroid dose
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
Proportion of participants who tapered off all corticosteroids
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [14] 0 0
Up to 3 years and 30 days
Secondary outcome [15] 0 0
Change from baseline in circulating monocyte number and phenotype (CD14/16)
Timepoint [15] 0 0
Up to 3 years and 30 days
Secondary outcome [16] 0 0
Change from baseline in soluble markers for bone resorption and formation, including bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide (CTX)
Timepoint [16] 0 0
Up to 3 years and 30 days

Eligibility
Key inclusion criteria
* = 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC = 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose = 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin > 1.5 × ULN and/or ALT and AST > 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2030
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Austin Health Medical Oncology and Clinical Haematology - Heidelberg
Recruitment postcode(s) [1] 0 0
02050 - Sydney
Recruitment postcode(s) [2] 0 0
03084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Linz Cet
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Vancouver
Country [14] 0 0
France
State/province [14] 0 0
Nancy
Country [15] 0 0
France
State/province [15] 0 0
Nantes
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Halle
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin 8
Country [20] 0 0
Italy
State/province [20] 0 0
Alessandria
Country [21] 0 0
Italy
State/province [21] 0 0
Rome
Country [22] 0 0
Italy
State/province [22] 0 0
San Giovanni Rotondo
Country [23] 0 0
Italy
State/province [23] 0 0
Verona
Country [24] 0 0
Japan
State/province [24] 0 0
Aichi
Country [25] 0 0
Japan
State/province [25] 0 0
Fukuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Hiroshima-shi
Country [27] 0 0
Japan
State/province [27] 0 0
Hyogo
Country [28] 0 0
Japan
State/province [28] 0 0
Isehara Kanagawa
Country [29] 0 0
Japan
State/province [29] 0 0
Kumamoto Kumamoto
Country [30] 0 0
Japan
State/province [30] 0 0
Maebashi
Country [31] 0 0
Japan
State/province [31] 0 0
Miyagi
Country [32] 0 0
Japan
State/province [32] 0 0
Okayama-ken
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Japan
State/province [34] 0 0
Sapporo Hokkaido
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Sevilla
Country [38] 0 0
Spain
State/province [38] 0 0
Zaragoza
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Albert Assad, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06585774