PreeclampsiaPhase 2NCT06333652
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
A Phase 2 study testing Ravulizumab in people with Preeclampsia, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with < 34 0/7 weeks of gestation.
- Individuals with severe preeclampsia or HELLP features.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gonzalez Suarez contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Maria L. Gonzalez Suarez, MD,PhD, 5072844083, gonzalezsuarez.maria@mayo.edu
About this study
Official title: Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
- Conditions
- Preeclampsia
- Being tested
- Ravulizumab
- Keywords
- Hemolysis, Elevated Liver enzymes, Low Platelets
- Medical subject headings
- Pre-Eclampsia, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Also called Ultomiris
Intravenous infusion 100 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Revulizumab Treatment | Experimental | Subjects will receive an single-dose infusion of Ravulizumab. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alternative Complement Pathway Biomarkers at time of delivery
Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery
Measured: Baseline
Secondary outcomes (4)
Pregnancy duration
Length of pregnancy measured in number of weeks.
Measured: Approximately 40 weeks
Clinical biomarkers of severe features of preeclampsia and HELLP syndrome
Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets
Measured: 72 hours after Ravulizumab infusion
Hospitalization length in the postpartum period
Length of hospital stay measured in number of days in hospital stay (peripartum period)
Measured: Approximately 3-5 days, it may vary
Meningococcal infection after use of ravulizumab
Number of participants to present a meningococcal infection after use of Ravulizumab
Measured: 72 hours up to 3 weeks after Ravulizumab infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Lourdes Gonzalez Suarez, Mayo Clinic
- Investigators
- Maria Lourdes Gonzalez Suarez, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333652
- Sponsor's protocol ID
- 22-009239
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
- ClinicalTrials.gov ID
- NCT06333652
- Acronym / sponsor ID
- 22-009239
- Conditions
- Preeclampsia
- Keywords
- Hemolysis, Elevated Liver enzymes, Low Platelets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revulizumab Treatment | Experimental | Drug: RavulizumabSubjects will receive an single-dose infusion of Ravulizumab. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals with < 34 0/7 weeks of gestation.
- Individuals with severe preeclampsia or HELLP features.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabAlso: UltomirisIntravenous infusion 100 mg/ml | Drug | Revulizumab Treatment |
Primary outcome
Alternative Complement Pathway Biomarkers at time of delivery
Time frame: Baseline
Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery
4 secondary outcomes
Pregnancy duration
Time frame: Approximately 40 weeks
Clinical biomarkers of severe features of preeclampsia and HELLP syndrome
Time frame: 72 hours after Ravulizumab infusion
Hospitalization length in the postpartum period
Time frame: Approximately 3-5 days, it may vary
Meningococcal infection after use of ravulizumab
Time frame: 72 hours up to 3 weeks after Ravulizumab infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gonzalez Suarez contact
Maria Lourdes Gonzalez Suarez, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ravulizumab in people with Preeclampsia, run by Mayo Clinic at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonzalez Suarez (507-284-2511), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alternative Complement Pathway Biomarkers at time of delivery (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.