Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease

September 16, 2021 updated by: ElsaLys Biotech

Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease Grade II-IV in Adults and in Children Over 28 Days of Age

Leukotac (inolimomab) is not approved yet for marketing in any region. In the absence of medical options and based on the safety and efficacy data obtained during the clinical development program (in a phase III (INO-107) and in a Long Term Follow Up study), the French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) and approved the temporary use protocol .

This early access program has been granted to Leukotac (inolimomab) in adults and in children over 28 days of age, for treatment of acute cortico-resistant or cortico-dependent grades II-IV acute graft versus host disease (GvHD) according to the Glucksberg classification after allogeneic hematopoietic stem cell transplantation.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

Despite improvements in allogeneic hematopoietic stem cell transplantation (allo-HSCT) settings, graft-versus-host disease (GvHD) remains a significant issue after transplantation and a major cause of non-relapse mortality. Acute GvHD (aGvHD) still develops in about 30% to 80% of patients, for which high dose corticosteroids can be initiated in those with grade ≥II. However, up to 50% of patients fail to obtain a satisfactory response with steroid treatment alone. Treatment of steroid-resistant (SR) aGvHD remains an unmet clinical need.

Inolimomab is an IgG1 mouse monoclonal antibody which specifically binds to the alpha chain of the human interleukin-2 receptor (CD25, IL-2R), a receptor expressed on the surface of the T cells in response in to antigenic stimulation.

Inolimomab efficacy in the treatment of corticosteroid-resistant graft-versus-host disease after allogenic hematopoietic stem cell transplant was assessed in a multicenter phase 3 randomized double-blind controlled study (INO-0107) versus Thymoglobulin® (anti-thymocyte globulin (ATG )).

Long term survival data were collected in the 43 surviving patients at the end of the phase 3 study INO-0107 (23 inolimomab; 20 ATG) and up to 104 months after discontinuation of treatment (median follow-up: 58.4 months). These long term follow-up data showed a statistically significant difference for survival with relative risk of death reduced by 43% in the inolimomab group (p=0.030). These data confirm the 1-year observations of the phase 3 study INO-0107 with a clear clinical benefit on survival statistically greater in patients receiving inolimomab.

Leukotac (inolimomab) is not approved yet for marketing in any region. This early access program has been granted to Leukotac (inolimomab) in adults and in children over 28 days of age, for treatment of acute cortico-resistant or cortico-dependent grades II-IV acute graft versus host disease (GvHD) according to the Glucksberg classification after allogeneic hematopoietic stem cell transplantation.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Available
        • ElsaLys Biotech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > or = 28 days
  • Grade II-IV acute graft versus host disease according to Glucksberg classification after allogeneic hematopoietic stem cell transplantation
  • Patients resistant or dependent to corticosteroid (CS)

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ElsaLys Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATUC-LKT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Steroid Resistant Acute Graft Versus Host Disease

Clinical Trials on inolimomab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe