ObservationalSolirisPMSNCT06448715
Real-World Treatment Study of Soliris (Eculizumab)
An observational study of Observational, run by AstraZeneca at 2 sites in South Korea.
Trial summary
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Observational
- How many people
- 11 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 May 2024to 3 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: According to the medical judgment of the investigator, patients who received Soliris in accordance with product label will be enrolled if they meet all the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
- Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
- Patient who understood and consented to the written informed consent provided.
Who cannot join
- Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
- Patients with untreated serious Neisseria meningitidis infection.
Trial locations and contacts
2 sites in 1 country.
About this study
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea.
This study will provide information on the population of Korean patients who are treated with Soliris.
Read the detailed description
The Korea Risk Management Plan (K-RMP) of Soliris Inj. 300mg (eculizumab, hereinafter referred to as 'Soliris' or study drug) includes Post-Marketing Surveillance (PMS) as part of the pharmacovigilance plan in accordance with 'Article 7-2 of Regulation on Pharmaceuticals Approval, Notification and Review'.
This study will be conducted to prepare data on drug use results required for post- marketing re-examination application of Soliris and the purpose of the study is to identify the safety under real world practice.
Soliris was approved by the Ministry of Food and Drug Safety on February 18, 2021 for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP-4) antibody positive, and a 4 years of re-examination period was given based on the approval date of the indication and usage change.
The re-examination period for Soliris is calculated as February 17, 2025 in accordance with the 'Standards for Re-examination of New Drugs, etc.' This study includes about 11 adult patients with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody currently treated with or initiating treatment with Soliris .
It will be conducted as a total surveillance method in which each subject who received the drug is recorded in the case report form during the study period. In addition, efforts will be made to conduct investigations on safety and efficacy, such as onset of side effect and expected effects, for all patients who received the product up to two years from the marketing date.
- Conditions
- Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
safety assessment of soliris
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
Measured: 24 weeks
Secondary outcomes (1)
efficacy assessment of Soliris
relapse of NMOSD
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start28 May 2024
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationalStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448715
- Sponsor's protocol ID
- D7412R00001
- Acronym
- SolirisPMS
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Study of Soliris (Eculizumab)
- ClinicalTrials.gov ID
- NCT06448715
- Acronym / sponsor ID
- SolirisPMS / D7412R00001
- Conditions
- Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 7 Jun 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.
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea.
This study will provide information on the population of Korean patients who are treated with Soliris.
Detailed description
The Korea Risk Management Plan (K-RMP) of Soliris Inj. 300mg (eculizumab, hereinafter referred to as 'Soliris' or study drug) includes Post-Marketing Surveillance (PMS) as part of the pharmacovigilance plan in accordance with 'Article 7-2 of Regulation on Pharmaceuticals Approval, Notification and Review'.
This study will be conducted to prepare data on drug use results required for post- marketing re-examination application of Soliris and the purpose of the study is to identify the safety under real world practice.
Soliris was approved by the Ministry of Food and Drug Safety on February 18, 2021 for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP-4) antibody positive, and a 4 years of re-examination period was given based on the approval date of the indication and usage change.
The re-examination period for Soliris is calculated as February 17, 2025 in accordance with the 'Standards for Re-examination of New Drugs, etc.' This study includes about 11 adult patients with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody currently treated with or initiating treatment with Soliris .
It will be conducted as a total surveillance method in which each subject who received the drug is recorded in the case report form during the study period. In addition, efforts will be made to conduct investigations on safety and efficacy, such as onset of side effect and expected effects, for all patients who received the product up to two years from the marketing date.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- According to the medical judgment of the investigator, patients who received Soliris in accordance with product label will be enrolled if they meet all the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
- Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
- Patient who understood and consented to the written informed consent provided.
Key exclusion criteria (2 listed)
- Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
- Patients with untreated serious Neisseria meningitidis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety assessment of soliris
Time frame: 24 weeks
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
1 secondary outcome
efficacy assessment of Soliris
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational, run by AstraZeneca at 2 sites in South Korea.
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 3 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety assessment of soliris (time frame: 24 weeks). 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 17 Dec 2025.