ClinicalTrials.gg
RecruitingNCT06333652Updated Oct 22, 2026

Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

A Phase 2 interventional study of Ravulizumab in Preeclampsia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Start date movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.

02

Conditions studied

  • Preeclampsia

Keywords

  • Hemolysis
  • Elevated Liver enzymes
  • Low Platelets
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 14 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals with \< 34 0/7 weeks of gestation.
  • Individuals with severe preeclampsia or HELLP features.

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Revulizumab Treatment

    Subjects will receive an single-dose infusion of Ravulizumab.

    Drug: Ravulizumab

Interventions

  • Intravenous infusion 100 mg/ml

    Also known as: Ultomiris

06

What researchers measure

Primary outcomes

  1. Alternative Complement Pathway Biomarkers at time of delivery

    Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery

    Time frame: Baseline

Secondary outcomes

  1. Pregnancy duration

    Length of pregnancy measured in number of weeks.

    Time frame: Approximately 40 weeks

  2. Clinical biomarkers of severe features of preeclampsia and HELLP syndrome

    Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets

    Time frame: 72 hours after Ravulizumab infusion

  3. Hospitalization length in the postpartum period

    Length of hospital stay measured in number of days in hospital stay (peripartum period)

    Time frame: Approximately 3-5 days, it may vary

  4. Meningococcal infection after use of ravulizumab

    Number of participants to present a meningococcal infection after use of Ravulizumab

    Time frame: 72 hours up to 3 weeks after Ravulizumab infusion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Apr 2027; primary completion for Dec 2028, 20 months later.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Apr 2027, on Oct 22, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2024
First posted
Mar 27, 2024
StartEst.
Apr 1, 2027was Sep 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Apr 1, 2027
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Start date Sep 1, 2026→Apr 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06333652
Lead sponsor
Mayo Clinic
Responsible party
Maria Lourdes Gonzalez Suarez (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 27, 2024
Start date
Apr 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Gonzalez Suarez
Contact
507-284-2511
Maria Lourdes Gonzalez Suarez, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ravulizumab

Start the discussion