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Could a drug for rare blood disorder help pregnant women with severe preeclampsia?

NCT ID NCT06333652

Disease control Sponsor: Mayo Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests ravulizumab (Ultomiris) in 14 pregnant individuals with severe preeclampsia or HELLP syndrome before 34 weeks of pregnancy. The drug aims to block part of the immune system that may drive these dangerous conditions. Researchers will measure blood markers and pregnancy duration to see if it helps.

What this could mean

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

Active substance
ravulizumab (Ultomiris)
What this could lead to
If successful, this could point toward a new treatment option for severe preeclampsia and HELLP syndrome, potentially improving outcomes for pregnant individuals.
What could go wrong
This is a very small early-phase trial with only 14 participants, so results may not apply broadly. The drug may not improve pregnancy outcomes or could have unforeseen risks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 14 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 years

Sex

Female participants only

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: * Individuals with \< 34 0/7 weeks of gestation. * Individuals with severe preeclampsia or HELLP features. Exclusion Criteria: * Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC). * Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (\<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.

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Conditions

The condition(s) this trial relates to.

HELLP syndrome Hemolysis preeclampsia severe pre-eclampsia

As listed by the trial registrant

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

Preeclampsia

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Mayo Clinic Minnesota

    RECRUITING

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.