Trial · NCT03298061

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

NCT03298061, Phase 3, Completed, GlaxoSmithKline; results first posted 2024-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921. Trials, record NCT03298061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03298061

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
NCT number: NCT03298061
Status: Completed
Phases: Phase 3
Enrollment: 100 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Interventions: Mepolizumab, Prednisolone
First posted: 2017-09-29
Last updated: 2024-03-12
Other registries' IDs: eudract:2014-003162-25
Results first posted: 2024-03-12

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to approximately 89 Months	An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events based on medical or scientific judgment; and is associated with liver injury and impaired liver function. Additionally, systemic (that is, allergic/hypersensitivity and non-allergic) reactions and local injection site reactions were recorded throughout the treatment and follow-up period.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to approximately 89 Months	Safety Population consisted of all participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Mepolizumab 300 mg	AE	98		Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Mepolizumab 300 mg	SAE	38		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mepolizumab 300 mg	100
Overall Study	COMPLETED	Mepolizumab 300 mg	73
Overall Study	NOT COMPLETED	Mepolizumab 300 mg	27

Source ClinicalTrials.gov

Adverse events147

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Mepolizumab 300 mg	4	100	5
other	Cataract	Eye disorders	Mepolizumab 300 mg	3	100	3
other	Abdominal distension	Gastrointestinal disorders	Mepolizumab 300 mg	3	100	3
other	Abdominal pain	Gastrointestinal disorders	Mepolizumab 300 mg	6	100	8
other	Abdominal pain upper	Gastrointestinal disorders	Mepolizumab 300 mg	4	100	26
other	Diarrhoea	Gastrointestinal disorders	Mepolizumab 300 mg	14	100	16
other	Gastritis	Gastrointestinal disorders	Mepolizumab 300 mg	4	100	5
other	Nausea	Gastrointestinal disorders	Mepolizumab 300 mg	14	100	18
other	Vomiting	Gastrointestinal disorders	Mepolizumab 300 mg	10	100	10
other	Asthenia	General disorders	Mepolizumab 300 mg	3	100	4

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mepolizumab 300 mg	1	100
Total, other adverse events	Mepolizumab 300 mg	97	100
Total, serious adverse events	Mepolizumab 300 mg	38	100

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40008472	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03298061

GET https://conductscience.org/api/trials/v1/NCT03298061/events?page=2

API reference For AI assistants