A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis (ADAPT SERON)

August 6, 2026 updated by: argenx

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 3.5 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Hôpital Erasme
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
      • Calgary, Canada, T2N 4Z6
        • Heritage Medical Research Clinic
      • Montreal, Canada, H4A 3T2
        • Genge Partners Inc.
      • Ottawa, Canada, K1H 8L6
        • Ottawa Hospital - Civic Campus
  • China
      • Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
      • Changchun, China, 130021
        • The First hospital of Jilin University
      • Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, China, 400016
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
      • Fuzhou, China, 350001
        • Fujian Medical University Union Hospital
      • Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Guangzhou, China, 510405
        • The First Affiliated Hospital of Guangzhou University Chinese Medicine
      • Guangzhou, China, 518053
        • Guangdong Province Traditional Chinese Medical Hospital
      • Guiyang, China, 550004
        • The Affiliated Hospital of Guizhou Medical University
      • Ningbo, China, 315041
        • Ningbo Medical Center Lihuili Hospital
      • Qingdao, China, 266035
        • Qilu Hospital of Shandong University
      • Shanghai, China, 200040
        • Huashan Hospital Fudan University
      • Taiyuan, China, 030001
        • First Hospital of Shanxi Medical University
      • Wuhan, China, 430030
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Cyprus
      • Égkomi, Cyprus, 2371
        • Cyprus Institute of Neurology and Genetics
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultní Nemocnice Brno
      • Pardubice, Czechia, 530 03
        • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • Finland
      • Turku, Finland, 20540
        • Turun yliopistollinen keskussairaala
  • France
      • Marseille, France, 13386
        • AP-HM- Hôpital de La Timone
      • Nice, France, 06000
        • CHU de Nice-Hôpital Pasteur
      • Paris, France, 75013
        • AP-HP - Hôpital de la Pitié Salpétrière
  • Georgia
      • Kutaisi, Georgia, 4600
        • West Georgia Medical Center
      • Tbilisi, Georgia, 0114
        • New Hospitals
      • Tbilisi, Georgia, 0112
        • Petre Sarajishvili Institute of Neurology
      • Tbilisi, Georgia, 0112
        • Pineo Medical Ecosystem
      • Tbilisi, Georgia, 0186
        • LLC Caucasus Medical Centre
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Bochum, Germany, 44791
        • Katholisches Klinikum Bochum - St. Josef Hospital
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Greece
      • Athens, Greece, 115 28
        • Eginitio Hospital
      • Chaïdári, Greece, 124 62
        • University General Hospital ''ATTIKON''
      • Pátrai, Greece, 265 04
        • University General Hospital of Patras
      • Thessaloniki, Greece, 546 36
        • AHEPA University General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1082
        • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Norway
      • Bergen, Norway, 5021
        • Haukeland Universitetssykehus
      • Oslo, Norway, 424
        • Oslo Universitetssykehus HF, Ullevål
  • Poland
      • Bydgoszcz, Poland, 85-065
        • MICS Centrum Medyczne Bydgoszcz
      • Katowice, Poland, 40-689
        • Centrum Medyczne Neurologia Slaska
      • Krakow, Poland, 31-503
        • Szpital Uniwersytecki w Krakowie
      • Krakow, Poland, 31-505
        • Krakowska Akademia Neurologii Sp. z o.o.
      • Lublin, Poland, 20-883
        • CLINIREM Sp z o.o.
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
  • Portugal
      • Lisbon, Portugal, 1150-199
        • ULS de Santa Maria, EPE - Hospital de Santa Maria
      • Lisbon, Portugal, 1349-019
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Porto, Portugal, 4050-011
        • Hospital de Santo António - Unidade Local de Saúde de Santo António
  • Romania
      • Cluj-Napoca, Romania, 400012
        • Cluj County Emergency Clinical Hospital
      • Sibiu, Romania, 550166
        • Sibiu Emergency County Clinical Hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Saudi Arabia, 14611
        • National Guard Riyadh
  • Serbia
      • Belgrade, Serbia, 11000
        • Opsta bolnica MSB - Medicinski Sistemi Beograd
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Dr. Balmis
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Barcelona, Spain, 8041
        • Hospital de La Santa Creu I Sant Pau
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Spain, 28304
        • Hospital Universitario Ramon Y Cajal
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TY
        • Panthera Biopartners
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • HonorHealth Neurology - Bob Bove Neuroscience Institute
    • California
      • Fresno, California, United States, 93701-2234
        • Loma Linda University Health
    • Florida
      • Boca Raton, Florida, United States, 33428
        • First Choice Neurology Boca Raton
      • Boca Raton, Florida, United States, 33487
        • SFM Clinical Research LLC
      • Coral Springs, Florida, United States, 33067
        • The Neurology Institute / Healthcare Innovations Institute - Coral Springs
      • Maitland, Florida, United States, 32751
        • Neurology Associates PA
      • Miami, Florida, United States, 33136
        • Desai Sethi Medical Center
      • Port Charlotte, Florida, United States, 33952
        • Medsol Clinical Research Center Inc
      • St. Petersburg, Florida, United States, 33705-1410
        • BayCare - St. Anthony's Hospital
      • Tampa, Florida, United States, 33612
        • University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Wellstar - Augusta University Medical Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Kansas University Medical Center - Kansas City
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901-1962
        • Rutgers-Robert Wood Johnson Medical School
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7025
        • University of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University School of Medicine - Duke Early Phase Clinical Research Unit
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403-2173
        • Erlanger Neuroscience Institute
    • Texas
      • Austin, Texas, United States, 78756
        • National Neuromuscular Research Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participant is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
  • The participant is capable of providing signed informed consent and following with protocol requirements.
  • The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the study drug.

  • The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following:

    1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is for anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive
    2. Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment
  • The participant is receiving a stable dose of MG therapy before screening, including acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone

Exclusion Criteria:

  • Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk
  • History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
  • Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
  • History of or current alcohol, drug, or medication abuse as assessed by the investigator
  • Pregnant or lactating state or intention to become pregnant during the study
  • Live or live-attenuated vaccine received <4 weeks before screening
  • Worsening muscle weakness secondary to concurrent infections or medications
  • Received a thymectomy less than 3 months before screening or thymectomy is planned during the study

The complete list of exclusion criteria can be found in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Efgartigimod IV
Patients receiving efgartigimod IV in both part A and part B
Biological: Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo Comparator: Placebo
Patients receiving placebo during part A and receiving efgartigimod IV during part B
Biological: Efgartigimod IV
Intravenous infusion of efgartigimod
Other: Placebo IV
Intravenous infusion of placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MG-ADL Total Score Change From Baseline
Time Frame: Up to 29 days in part A
The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms).
Up to 29 days in part A

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
QMG Total Score Change From Baseline
Time Frame: Up to 29 days in part A
The Quantitative Myasthenia Gravis (QMG) score includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no symptoms) to 39 (highest disease severity).
Up to 29 days in part A
Proportion of Participants Who Are Both MG-ADL and QMG Responders in Part A
Time Frame: Up to 8 weeks (part A)
A participant was an MG-ADL responder if there was a ≥2-point reduction in the MG-ADL total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A. A participant was a QMG responder if there was a ≥3-point reduction in the QMG total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A.
Up to 8 weeks (part A)
Proportion of Participants With MSE
Time Frame: Up to 8 weeks (part A) + 3 years (part B)
Minimal symptom expression (MSE) is defined as an MG-ADL total score of 0 or 1
Up to 8 weeks (part A) + 3 years (part B)
Proportion of Participants Who Are MG-ADL Responders in Part A
Time Frame: Up to 8 weeks (part A)
The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). A participant was an MG-ADL responder if there was a ≥2-point reduction in the MG-ADL total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A.
Up to 8 weeks (part A)
Proportion of Participants Who Are QMG Responders in Part A
Time Frame: Up to 8 weeks (part A)
The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no symptoms) to 39 (highest disease severity). A participant was a QMG responder if there was a ≥3-point reduction in the QMG total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A.
Up to 8 weeks (part A)
Proportion of Participants Who Are Early MG-ADL Responders in Part A
Time Frame: Up to 8 weeks (part A)
The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). An Early MG-ADL responder is an MG-ADL responder who had an onset of an MG-ADL response no later than 2 weeks after the first administration of IMP in part A.
Up to 8 weeks (part A)
MG-ADL Total Score Change From Baseline Over Time in Part A and Part A+B
Time Frame: Up to 8 weeks (part A) + 3 years (part B)
The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms).
Up to 8 weeks (part A) + 3 years (part B)
MG-QoL15r Change From Baseline Over Time in Part A and Part A+B
Time Frame: Up to 8 weeks (part A) + 3 years (part B)
The Myasthenia Gravis Quality of Life-15 revised (MG-QoL15r) is a patient-reported instrument that measures the impact of MG symptoms on quality of life. The total scores range from 0 (best outcome) to 30 (worst outcome).
Up to 8 weeks (part A) + 3 years (part B)
EQ-5D-5L VAS Change From Baseline Over Time in Part A and Part A+B
Time Frame: Up to 8 weeks (part A) + 3 years (part B)
The EQ-5D-5L is a participant-reported measure of health status developed by the EuroQol Group. The questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Current health status is rated on vertical visual analog score (VAS) from 0 to 100, with a score of 0 corresponding to "the worst health you can imagine" and 100 corresponding to "the best health you can imagine."
Up to 8 weeks (part A) + 3 years (part B)
Total IgG Concentrations Percent Changes From Baseline Over Time in Part A and Part A+B
Time Frame: Up to 8 weeks (part A) + 3 years (part B)
Up to 8 weeks (part A) + 3 years (part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARGX-113-2308
  • 2024-511796-15-00 (Other Identifier: CTIS number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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