EUCTR2021-004588-29-ES
Active, not recruiting
Phase 1
A randomized, double-blind trial to evaluate the safety and efficacy of apraglutide in subjects with Grade II to IV (MAGIC) steroid refractory gastrointestinal (GI) acute graft versus host disease on best available therapy - Proof-of-concept trial of apraglutide in GVHD
ConditionsAcute graft versus host disease (GVHD)MedDRA version: 20.0Level: PTClassification code 10075160Term: Graft versus host disease in gastrointestinal tractSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: LLTClassification code 10075161Term: Graft versus host disease in GI tractSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute graft versus host disease (GVHD)
- Sponsor
- VectivBio AG
- Enrollment
- 34
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent for this trial prior to any trial specific assessment. A signed assent form will also be required for any subjects under the age of 18 years
- •2\. Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg
- •3\. Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo\-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non\-myeloablative, myeloablative, and reduced intensity conditioning are eligible
- •4\. Evident myeloid and platelet engraftment (confirmed prior to trial medication start):
- •a) Absolute neutrophil count \>1000/mm3
- •b) Platelets \=20,000/mm3
- •Use of growth factor supplementation (granulocyte\-colony stimulating factor and granulocyte\-macrophage\-colony stimulating factor) and transfusion support is allowed
- •5\. Histologically diagnosed GI\-aGVHD at screening (with clinically confirmed SR GI\-aGVHD at RUX start and prior to apraglutide start) defined as subjects administered SS, given alone or combined with calcineurin inhibitors (CNI) and either:
- •a) Disease progression based on organ assessment after 3 days
- •b) Did not improve after 7 days of treatment with MP 2mg/kg/day equivalent,
Exclusion Criteria
- •1\. Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil. For subjects on GVHD prophylaxis (ciclosporin A, tacrolimus, sirolimus, everolimus, or anti\-thymocyte globulin) this medication can be continued
- •2\. Concomitant treatment with Janus kinase inhibitor therapy for any other indication after initiation of current alloSCT conditioning
- •3\. Presence of any systemic corticosteroid therapy for indications other than aGVHD within 7 days prior to screening. Low doses of prednisolone/hydrocortisone for adrenal suppression are allowed
- •4\. Failed alloSCT within the past 6 months before randomization
- •5\. Presence of SR GI\-aGVHD occurring after non\-scheduled donor lymphocyte infusion administered for pre\-emptive treatment of malignancy recurrence
- •6\. Previous administration of any investigational treatment agent within 30 days prior to screening or within five half\-lives of the trial medication, whichever is greater. Subjects who have received placebo in a previous study during this period may be included.
- •7\. Known or suspected hypersensitivity to GLP\-1 or GLP\-2 analogs or apraglutide excipients
- •8\.Any use of enteral glutamine or growth factors such as native GLP\-2, GLP\-1 or GLP\-2 and GLP\-1 analogs within 6 months prior to randomization
- •9\.Inability to understand or adhere to the trial visit schedules and other protocol requirements, including subjects not willing to comply due to drug/alcohol abuse or any condition that would interfere with full participation in the trial, including administration of trial medication and attending required trial visits; pose a significant risk to the subject; or interfere with interpretation of trial data
- •10\. Less than 2 weeks anticipated survival at screening
Outcomes
Primary Outcomes
Not specified
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