Trial · NCT07591753
Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)
NCT07591753, Completed, European EGPA Study Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study). Trials, record NCT07591753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07591753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)
- NCT number
- NCT07591753
- Status
- Completed
- Enrollment
- 299 participants, actual
- Lead sponsor
- European EGPA Study Group
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)
- Interventions
- Mepolizumab 300 mg
- First posted
- 2026-05-18
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete and Partial Response | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients achieving complete response or partial response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day. |
| Primary | Change in Lung Function | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) during follow-up. |
| Primary | Disease relapses | Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with disease relapse during follow-up. Relapse is defined as active vasculitis (BVAS\>0) and/or worsening asthma or ENT manifestations leading to oral corticosteroid increase to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization. |
| Primary | Respiratory Exacerbations | Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with respiratory exacerbations during follow-up. Respiratory exacerbations are defined as asthma attack requiring an increase in oral corticosteroid dose \>30%, emergency department admission related to asthma, and/or use of acute oral corticosteroids, antibiotics, or short-acting beta-agonists. |
| Secondary | Proportion of Patients With at Least One Adverse Event or Serious Adverse Event | Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with at least one adverse event (AE) or serious adverse event (SAE) during treatment with mepolizumab 300 mg/4 weeks. Safety events are retrieved from medical charts and summarized as aggregated data. |
| Secondary | Persistance | Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months) | Persistence on mepolizumab, assessed in terms of dose switching and treatment discontinuation during follow-up. |
| Other | Changes in Organ Manifestations | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | The proportion of patients with active symptoms will be calculated over the total number of patients with available data for the given timepoint. |
| Other | Oral Corticosteroid-Sparing Effect | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Median daily oral corticosteroid dose and proportion of patients achieving a daily oral corticosteroid dose of 0 during follow-up |
| Other | DMARD-Sparing Effect | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients discontinuing DMARD treatment that was ongoing or newly started at baseline. |
| Other | Variation in ANCA Positivity | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of ANCA-positive patients at each timepoint and ANCA negativization among patients positive for ANCA at baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07591753
GET https://conductscience.org/api/trials/v1/NCT07591753/registered