NUCALA® Special Drug Use Investigation (EGPA, Long-term)

NCT03557060 | Completed Results

• 1 other identifier: 208505
• Study Type: observational
• Target: 4,115
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies.

Conditions

Churg-Strauss Syndrome; Eosinophilic Granulomatosis With Polyangiitis

Keywords

Nucala; Drug use investigation; EGPA; Long-term

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Drug Reactions (ADRs)

  ADR is defined as adverse events for which a causal relationship with the drug was not ruled out.

  Up to 96 Weeks

• Response Rate Based on Global Assessment of Effectiveness

  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.

  Up to 96 Weeks

• Time to EGPA Relapse

  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.

  Up to 96 Weeks

Study Arms (1)

Participants with EGPA

Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study

Drug: Nucala

Interventions

Nucala DRUG

NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Participants with EGPA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study.

You may qualify if:

• All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
• Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 107-0052, Japan

Location

Related Publications (1)

• Fujii T, Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Matsuno H, Mukai I, Ishida A, Aizawa K, Kuwana M, Takagi M, Takeuchi T.Post-marketing surveillance of mepolizumab use in patients with eosinophilic granulomatosis with polyangiitis in Japan: Interim analysis.Ther Res.2021;42(6):403-422

  BACKGROUND

MeSH Terms

Conditions

Churg-Strauss Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: June 25, 2018
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 18, 2026
• Results First Posted: February 18, 2026

Record last verified: 2026-01

Locations

JP (1)