Low-dose Interleukin-2 in Women With Unexplained Miscarriages

• Status: Recruiting
• Trial end date: 2025-02-05
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Iltoo Pharma
• Treatments: Interleukin-2

Criteria

Inclusion Criteria:

• Woman with at least 5 consecutive early miscarriages less than 14 weeks of amenorrhea and unexplained after the usual check-up;

• Volunteer to participate in the trial and having given written consent after appropriate information.

Exclusion Criteria:

• Uterine or pelvic abnormality: uterine malformation, intracavitary fibroid, synechiae, polyp, hydrosalpinx;

• Balanced translocations in both spouses;

• Diabetes type I or II;

• Sickle cell disease;

• Contraindication to pregnancy;

• Constitutional or acquired thrombophilia (protein deficit C, S, ATIII, homozygous factor V or II deficiency, antiphospholipid syndrome, antithyroid antibodies positive, celiac disease, hyperhomocysteinemia);

• Ovarian insufficiency (AMH <1 μg/ml);

• Active HIV or HCV infection;

• Main known contraindications to treatment with IL-2:

• Hypersensitivity to the active substance or to any of the excipients;

• Signs of progressive infection requiring antibiotic therapy;

• History of organ allograft;

• Pre-existing autoimmune disease;

• Leukocytes <4000 / mm3; platelets <100,000 / mm3; hematocrit <30%;

• hepatic or renal insufficiency;

• depression;

• heart failure (ECG);

• patients with autoimmune disease;

• patients with an infection (septicemia, bacterial endocarditis, septic thrombophlebitis, peritonitis and pneumonia);

• pregnancy;

• Treatment with immunomodulators, immunosuppressants (class L04A of the ATC classification), in particular systemic corticosteroids, as well as aspirin and low molecular weight heparin;

• No affiliation to a social security;

• Person who has already been included in this study or in another at the same time;

• Major incapacitated patient (tutorship / curatorship);

• Patient with an allergy to taking IL2-fd;

• Participants who would present professional risk factors (eg ionizing exposure);