Steroid Resistant Acute Graft Versus Host DiseaseNCT05047328
Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease
A study testing inolimomab in people with Steroid Resistant Acute Graft Versus Host Disease, run by ElsaLys Biotech at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Steroid Resistant Acute Graft Versus Host Disease
- What is being tested?
- inolimomab
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
- Available
ElsaLys Biotech
Lyon
Raphaele Beaudet, +33 (0) 6 85 06 46 23, relationshospitalieres_RB@elsalysbiotech.com
About this study
Official title: 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.
Read the 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.
- Being tested
- inolimomab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inolimomabBiological
Also called Leukotac
1 or 2 Induction Phases at 0.3 mg/kg/day for adults or 0.4 mg/kd/day for children over 8 consecutive days If no complete response (CR) occurs after 8 days, a second induction phase is conducted until day 16 (even if CR is obtained before completion of the second induction phase).
Maintenance Phase: 0.4 mg/kg administered 3 times a week until Day 28 In case of a CR at day 9, the maintenance phase will start after day 9 and will be sustained until day 28.
In case of a CR, partial response (PR) or mixed response (MR) at day 17, the maintenance phase will start after day 17 and will be sustained until day 28.
Total duration of treatment is 28 ±2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid Resistant Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- ElsaLys Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047328
- Sponsor's protocol ID
- ATUC-LKT
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05047328
- Acronym / sponsor ID
- ATUC-LKT
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- ElsaLys BiotechIndustry (pharma, biotech, devices)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inolimomabAlso: Leukotac1 or 2 Induction Phases at 0.3 mg/kg/day for adults or 0.4 mg/kd/day for children over 8 consecutive days If no complete response (CR) occurs after 8 days, a second induction phase is conducted until day 16 (even if CR is obtained before completion of the second induction phase). Maintenance Phase: 0.4 mg/kg administered 3 times a week until Day 28 In case of a CR at day 9, the maintenance phase will start after day 9 and will be sustained until day 28. In case of a CR, partial response (PR) or mixed response (MR) at day 17, the maintenance phase will start after day 17 and will be sustained until day 28. Total duration of treatment is 28 ±2 days. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inolimomab in people with Steroid Resistant Acute Graft Versus Host Disease, run by ElsaLys Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphaele Beaudet (+33 (0) 6 85 06 46 23, relationshospitalieres_RB@elsalysbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021; AzTrials last refreshed its copy on 1 Nov 2026.