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Weekly shot may protect joints in hemophilia a

NCT ID NCT06941870

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a once-weekly infusion of efanesoctocog alfa can improve joint swelling (synovial hypertrophy) in people with moderate to severe hemophilia A. Researchers will use ultrasound to measure changes in joint health over 12 months. The trial enrolls 35 participants aged 12 and older who already have joint swelling.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Efanesoctocog alfa (a clotting factor medicine given intravenously once a week)
What this could lead to
If it works, this could show that weekly infusions of efanesoctocog alfa reduce joint damage and improve joint health in people with hemophilia A.
What could go wrong
This is a small, early-phase study with only 35 participants and no comparison group. It may not prove long-term benefit or work for everyone. Risks include infusion reactions and potential for developing inhibitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent/assent. Participant is more than or equal to (≥)12 years old at the time of consent/assent. Participant has existing synovial hypertrophy, defined as at least 1 eligible\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent/assent. Participant has at least 1 eligible\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1). \*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2). Participant is capable of understanding the written Informed Consent Form (ICF)/assent form, provides a signed and witnessed written ICF/assent form, and agrees to comply with the protocol requirements. If male, no contraceptive measures are required for this study. If female, is not pregnant or breastfeeding, and one of the following conditions applies: Is a women of nonchildbearing potential (WONCBP) Is a women of childbearing potential (WOCBP) and agrees to use a highly effective contraceptive method, with a failure rate of less than (\<)1 percent during the study treatment period (at least until the Week 52/ End of Treatment \[EoT\] visit). A WOCBP must have a negative serum pregnancy test at the screening visit (Visit 1) Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Has other associated clotting disorders at the time of consent/assent. Is already under efanesoctocog alfa treatment. Has a current diagnosis of an factor VIII (FVIII) inhibitor, defined as inhibitor titer ≥0.60 BU/mL. Has ITI within the last 2 years prior to the baseline visit (Visit 2). Has been enrolled in a concurrent clinical interventional study or exposed to other investigational drug(s) within 3 months prior to screening for this study. Is currently in an institution because of regulatory or legal order (that is, is a prisoner or a patient who is legally institutionalized). Is not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. Is an employee or family member of the investigator or site personnel. Is involved in a specific situation during study implementation or the course of the study that may raise ethics considerations. Has hypersensitivity to efanesoctocog alfa or its components or any of its excipients that, in the opinion of the investigator, contraindicates participation in the study.

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Factor viii deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Innovative Hematology, Inc.- Site Number : 8400006

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Investigational Site Number : 1240003

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • Investigational Site Number : 1240004

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • Investigational Site Number : 1580001

    RECRUITING

    Taichung, 407, Taiwan

  • Investigational Site Number : 1580002

    RECRUITING

    Taipei, 114, Taiwan

  • Investigational Site Number : 1580003

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Investigational Site Number : 3920001

    RECRUITING

    Saitama, 330-8777, Japan

  • Investigational Site Number : 3920002

    RECRUITING

    Hiroshima, 734-8551, Japan

  • Investigational Site Number : 3920003

    RECRUITING

    Kawasaki, Kanagawa, 216-8511, Japan

  • Investigational Site Number : 3920004

    RECRUITING

    Tokyo, 160-0023, Japan

  • Ohio State University Hospital East- Site Number : 8400001

    RECRUITING

    Columbus, Ohio, 43203-1779, United States

  • Orthopedic Institute for Children- Site Number : 8400009

    RECRUITING

    Los Angeles, California, 90007, United States

  • University of Iowa- Site Number : 8400004

    RECRUITING

    Iowa City, Iowa, 52242, United States

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