NCT03970954

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2021

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

March 14, 2019

Last Update Submit

September 10, 2025

Conditions

Recurrent Miscarriage

Keywords

Low-dose Interleukin-2MiscarriageRegulatory T cells

Outcome Measures

Primary Outcomes (5)

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

    Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2

    At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1]

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

    Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2

    At the day 66 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

    Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2

    At the day 94 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

    Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2

    At the day 122 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

    Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2

    At the day 150 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 11

Secondary Outcomes (5)

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers)

    At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers)

    At the day 66 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers)

    At the day 94 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers)

    At the day 122 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

  • Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers)

    At the day 150 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 11

Study Arms (1)

1

EXPERIMENTAL

Low-dose IL-2

Drug: low-dose IL-2

Interventions

low-dose IL-2DRUG

Subcutaneous injection of low dose of IL-2 for induction course of 5 days, the 10th day after the beginning of periods. At most 5 courses of low dose of IL-2.

Also known as: interleukin-2
1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 ng/ml); AFC \< 4
  • Significant spermogram abnormalities and DNA fragmented more than 30%
  • 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%;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mekinian

Paris, Hopital Saint Antoine, 75012, France

Location

Bornes

Paris, Hopital Tenon, 75020, France

Location

Kayem

Paris, Hopital Trousseau, 75012, France

Location

MeSH Terms

Conditions

Abortion, HabitualAbortion, Spontaneous

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • David Klatzmann, Pr

    Pitié Salpètrière APHP Paris

    PRINCIPAL INVESTIGATOR

  • Arsene Mékinian, Dr

    Saint Antoine APHP Paris

    STUDY DIRECTOR

  • Gilles Kayem, Pr

    Trousseau APHP Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

June 3, 2019

Study Start

January 5, 2021

Primary Completion

July 28, 2023

Study Completion

March 20, 2024

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)