Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE-XT)

August 11, 2026 updated by: UCB Biopharma SRL

A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis

The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.
200

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 Locations

  • Canada
      • Montreal, Canada
        • Mg0011 11
  • France
      • Lille, France
        • Mg0011 204
      • Nice, France
        • Mg0011 118
      • Paris, France
        • Mg0011 105
      • Strasbourg, France
        • Mg0011 137
  • Germany
      • Göttingen, Germany
        • Mg0011 150
      • Tübingen, Germany
        • Mg0011 129
  • Italy
      • Milan, Italy
        • Mg0011 132
      • Roma, Italy
        • Mg0011 126
  • Japan
      • Chiba, Japan
        • Mg0011 151
      • Hanamaki-shi, Japan
        • Mg0011 136
      • Kita-gun, Japan
        • Mg0011 179
      • Meguro-ku, Japan
        • Mg0011 153
      • Nagasaki, Japan
        • Mg0011 146
      • Narita, Japan
        • Mg0011 169
      • Sapporo, Japan
        • Mg0011 152
      • Sendai, Japan
        • Mg0011 144
      • Shinjuku-ku, Japan
        • Mg0011 163
      • Tokyo, Japan
        • Mg0011 141
  • Norway
      • Bergen, Norway
        • Mg0011 140
      • Oslo, Norway
        • Mg0011 143
  • Poland
      • Katowice, Poland
        • Mg0011 195
      • Katowice, Poland
        • Mg0011 213
      • Krakow, Poland
        • Mg0011 192
      • Krakow, Poland
        • Mg0011 193
      • Krakow, Poland
        • Mg0011 211
      • Lodz, Poland
        • Mg0011 214
      • Lublin, Poland
        • Mg0011 205
      • Nowa Sól, Poland
        • Mg0011 194
      • Poznan, Poland
        • Mg0011 209
      • Warsaw, Poland
        • Mg0011 201
      • Zabrze, Poland
        • Mg0011 210
  • Spain
      • Barcelona, Spain
        • Mg0011 133
      • Barcelona, Spain
        • Mg0011 168
      • Bilbao, Spain
        • Mg0011 138
  • United Kingdom
      • Oxford, United Kingdom
        • Mg0011 119
      • Sheffield, United Kingdom
        • Mg0011 130
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Mg0011 41
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Mg0011 116
    • California
      • Irvine, California, United States, 92697
        • Mg0011 31
      • Los Angeles, California, United States, 90033
        • MG0011 4
      • Pasadena, California, United States, 91101
        • Mg0011 220
      • San Francisco, California, United States, 94115
        • Mg0011 160
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Mg0011 24
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052
        • Mg0011 27
    • Florida
      • Tampa, Florida, United States, 33612
        • Mg0011 25
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Mg0011 135
    • Illinois
      • Glenview, Illinois, United States, 60026-1339
        • Mg0011 188
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Mg0011 156
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mg0011 32
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Mg0011 33
      • East Lansing, Michigan, United States, 48824
        • Mg0011 49
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Mg0011 134
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Mg0011 117
    • New York
      • Buffalo, New York, United States, 14202-1102
        • Mg0011 30
      • Great Neck, New York, United States, 11021
        • Mg0011 123
      • New York, New York, United States, 10021
        • Mg0011 23
      • New York, New York, United States, 10029
        • Mg0011 47
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Mg0011 22
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Mg0011 122
      • Columbus, Ohio, United States, 43210
        • Mg0011 38
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Mg0011 40
    • South Carolina
      • Charleston, South Carolina, United States, 29425-8908
        • Mg0011 128
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Mg0011 28
    • Texas
      • Austin, Texas, United States, 78759
        • Mg0011 131
      • Dallas, Texas, United States, 75390
        • Mg0011 19
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Mg0011 39
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Mg0011 164
    • Washington
      • Seattle, Washington, United States, 98195
        • Mg0011 154
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Mg0011 45

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Completion of a qualifying zilucoplan study

Exclusion Criteria:

  • With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: 0.3 mg/kg zilucoplan (RA101495)
Drug: zilucoplan (RA101495)
Daily subcutaneous (SC) injection

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
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)
A treatment-emergent adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)

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
Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
Time Frame: From Baseline (Day 1) to Week 12
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 8 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe).
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score
Time Frame: From Baseline (Day 1) to Week 12
The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score
Time Frame: From Baseline (Day 1) to Week 12
The MGC is a 10-item scale that has been used to measure the clinical status of patients with Myasthenia Gravis (MG) in order to evaluate treatment response. The MGC has 4-point Likerttype Scale response options ranging from 0 to 2, 3, 4, 5, 6 or 9 according to the item (weighted response options). The total score is the sum of all items (range 0-50) where higher scores indicate more severe impairment due to the disease.
From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score
Time Frame: From Baseline (Day 1) to Week 12
The MG-QOL15r is a 15-item survey that was designed to assess quality of life in patients with MG. The MG-QoL has 3-point Likert Scale response options ranging from 0 to 2. The MGQoL15r score can range from 0 to 30, where higher scores indicate more severe impact of the disease on aspects of the patient's life.
From Baseline (Day 1) to Week 12

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.
UCB Biopharma SRL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, 001 844 599 2273

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.

General Publications

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.
December 23, 2019

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.
July 31, 2026

Study Completion (Actual)

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.
July 31, 2026

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).
October 2, 2019

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.
January 8, 2020

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.
January 13, 2020

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 12, 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 11, 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.
August 1, 2026

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.
  • RA101495-02.302
  • 2024-512399-37 (Registry Identifier: EU Clinical Trials)
  • U1111-1306-6625 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD Sharing Time Frame

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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