Belimumab CTD-ILD - Long Term Extension/Follow up to pivotal studies BLISSc-ILD and BEconneCTD-ILD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

3 Jun 2025 → ongoing

Decision date (initial)

2025-01-17

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

GlaxoSmithKline Research & Development Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To describe the long-term safety and tolerability of belimumab treatment in participants with SSc- ILD and other CTD-ILDs

Secondary objectives 1

1. To describe the long-term effect of belimumab on lung function in participants with SSc-ILD and other CTD-ILDs

Conditions and MedDRA coding

connective tissue diseases

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, European Medicines Agency, Food And Drug Administration, National Medical Products Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria: INC#1 o Initiation of new immunosuppressive or immunomodulatory medication for SSc or other CTD-related disease activity/progression since joining study 218224 or 221672. o Increase of systemic corticosteroids beyond the allowed limits, for SSc or other CTD-related disease activity/progression since joining study 218224 or 221672 o Discontinuation of study medication during study 218224 or 221672 for any reason.
2. Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh.
3. Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to administer the study medication throughout the study
4. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: INC#4 o Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Section 10.4: Contraceptive and Barrier Guidance. OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 (Appendix 4: Contraceptive and Barrier Guidance) during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. − A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. See Section 8.3.5. − If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. − Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. − The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria 4

1. Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52
2. Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk
3. Participants who have developed any other medical diseases (e.g.., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that, in the opinion of the investigator could significantly alter the absorption, metabolism, or elimination of drugs; constitutes a risk when taking the study intervention; interferes with the interpretation of data; or it is not safe for the participant to continue on the study
4. Participants who have been exposed to ionizing radiation in excess of 10 mSv above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of AEs, AESIs and SAEs

Secondary endpoints 1

1. Absolute change from baseline* in FVC (mL) at OLE Weeks 12, 26 and 52.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

G S K House, 980 Great West Road 980 Great West Road

City

Brentford

Postcode

TW8 9GS

Country

United Kingdom

Scientific contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 20

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

79 New Oxford Street

City

London

Postcode

WC1A 1DG

Country

United Kingdom

Sponsor responsibilities

Article 77 compliance

Glaxosmithkline Research & Development Limited

Contact point sponsor

Glaxosmithkline Research & Development Limited

Article 77 implementation

Glaxosmithkline Research & Development Limited

Locations

8 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 79 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications