Trial · NCT03557060
NUCALA® Special Drug Use Investigation (EGPA, Long-term)
NCT03557060, Completed, GlaxoSmithKline; results first posted 2026-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NUCALA® Special Drug Use Investigation (EGPA, Long-term). Trials, record NCT03557060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03557060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NUCALA® Special Drug Use Investigation (EGPA, Long-term)
- NCT number
- NCT03557060
- Status
- Completed
- Enrollment
- 4,115 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
- Interventions
- Nucala
- First posted
- 2018-06-14
- Last updated
- 2026-02-18
- Results first posted
- 2026-02-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions (ADRs) | Up to 96 Weeks | ADR is defined as adverse events for which a causal relationship with the drug was not ruled out. |
| Primary | Response Rate Based on Global Assessment of Effectiveness | Up to 96 Weeks | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off. |
| Primary | Time to EGPA Relapse | Up to 96 Weeks | EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above. |
Source ClinicalTrials.gov
Outcomes3
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 Drug Reactions (ADRs) | Up to 96 Weeks | Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Response Rate Based on Global Assessment of Effectiveness | Up to 96 Weeks | Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| PRIMARY | Time to EGPA Relapse | Up to 96 Weeks | Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. | Days | MEAN |
Source ClinicalTrials.gov
Results by group3
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 Drug Reactions (ADRs) | Participants With EGPA | 57 | Participants | ||
| Response Rate Based on Global Assessment of Effectiveness | Participants With EGPA | 95.1 | Percentage of Participants | ||
| Time to EGPA Relapse | Participants With EGPA | 133.7 | Standard Deviation 160.5 | Days |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With EGPA | 4,115 | |
| Overall Study | Safety Analysis Population | Participants With EGPA | 836 | |
| Overall Study | Locked Case Report Forms | Participants With EGPA | 847 | |
| Overall Study | COMPLETED | Participants With EGPA | 687 | |
| Overall Study | NOT COMPLETED | Participants With EGPA | 3,428 |
Source ClinicalTrials.gov
Adverse events60
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 | Malaise | General disorders | Participants With EGPA | 7 | 836 | |
| other | Condition aggravated | General disorders | Participants With EGPA | 1 | 836 | |
| other | Asthenia | General disorders | Participants With EGPA | 1 | 836 | |
| other | Injection site pain | General disorders | Participants With EGPA | 1 | 836 | |
| other | Injection site pruritus | General disorders | Participants With EGPA | 1 | 836 | |
| other | Injection site reaction | General disorders | Participants With EGPA | 1 | 836 | |
| other | Pyrexia | General disorders | Participants With EGPA | 1 | 836 | |
| other | Application site purpura | General disorders | Participants With EGPA | 1 | 836 | |
| other | Herpes zoster | Infections and infestations | Participants With EGPA | 4 | 836 | |
| other | Bronchitis | Infections and infestations | Participants With EGPA | 3 | 836 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With EGPA | 1 | 836 |
| Total, other adverse events | Participants With EGPA | 46 | 836 |
| Total, serious adverse events | Participants With EGPA | 15 | 836 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03557060
GET https://conductscience.org/api/trials/v1/NCT03557060/events?page=2