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Recurrent MiscarriagePhase 1/2FaCIL-2NCT03970954

Low-dose Interleukin-2 in Women With Unexplained Miscarriages

A Phase 1/2 study testing low-dose IL-2 in people with Recurrent Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Recurrent Miscarriage
What is being tested?
low-dose IL-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesFrance
Study dates
5 Jan 2021to 20 Mar 2024
Phase
Phase 1/2
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 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 27Show fewer
  • 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%;
  • hepatic or renal insufficiency;
  • depression;
  • significant history or existence of a serious heart disease (in doubtful cases, perform a stress test);
  • 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);

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Mekinian

    Paris, Hopital Saint Antoine, 75012

  • Bornes

    Paris, Hopital Tenon, 75020

  • Kayem

    Paris, Hopital Trousseau, 75012

Other trials in France

About this study

Official title: Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages

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.

Read the detailed description

About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages that may be related to parental chromosomal abnormalities, uterine abnormalities, hormonal causes, infectious etiology, thrombophilia ... When one of these known causes is excluded, it is unexplained miscarriages of which half would be due to an immunological deregulation of the mother causing a decrease of the tolerance to the fetus.

In this context, the stimulation of regulatory T cells (Tregs) by low dose IL-2 is a therapeutic option with a rational, preclinical and clinical data very favorable.

In humans, low dose IL-2 allows preferential activation of Tregs and is very well tolerated. Several therapeutic trials have shown its efficiencies.

These elements make it possible to envisage the development of a therapeutic to prevent fetal rejection by IL2-fd on the women with spontaneous miscarriages by an immunological deregulation.

Being tested
low-dose IL-2
Keywords
Low-dose Interleukin-2, Miscarriage, Regulatory T cells
Medical subject headings
Abortion, Habitual, Abortion, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-dose IL-2Drug

    Also called interleukin-2

    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.

Study groups in NCT03970954
Study groupRoleWhat they receive
1ExperimentalLow-dose IL-2
Receives: Drug: low-dose IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

  2. 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

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

  3. 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

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

  4. 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

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

  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

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

Secondary outcomes (5)

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start5 Jan 2021
  3. Primary completion28 Jul 2023
  4. Study completion20 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970954
Sponsor's protocol ID
APHP180256
Acronym
FaCIL-2
Status last verified
Sep 2025
First submitted
14 Mar 2019
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing low-dose IL-2 in people with Recurrent Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 2 inclusion and 27 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) (time frame: At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970954.

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 12 Sep 2025.

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