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A Phase 2, randomized, double-blind, placebo-controlled, parallel group study (TRANSFORM) to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509371-16-00
Acronym
220929
Enrollment
78
Registered
2024-05-30
Start date
2024-09-25
Completion date
2025-09-30
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

Absolute change from baseline in FVC (mL) at Week 26

Detailed description

Absolute change from baseline in FVC (mL) at Weeks 4, 8, 12 and 18, Absolute change from baseline in FVC (% predicted) at Weeks 4, 8, 12, 18 and 26, Participants achieving relative decline from baseline in FVC (mL) ≤ 5% at Week 26, Participants with of AEs/SAEs over 26 weeks, "Participants with of clinically important findings in: - Vital signs, including blood pressure, body temperature, and pulse rate - Electrocardiogram - Laboratory: haematology, hepatobiliary, clinical chemistry "

Interventions

DRUGPlacebo to Match GSK3915393 Tablet

Sponsors

Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change from baseline in FVC (mL) at Week 26

Secondary

MeasureTime frame
Absolute change from baseline in FVC (mL) at Weeks 4, 8, 12 and 18, Absolute change from baseline in FVC (% predicted) at Weeks 4, 8, 12, 18 and 26, Participants achieving relative decline from baseline in FVC (mL) ≤ 5% at Week 26, Participants with of AEs/SAEs over 26 weeks, "Participants with of clinically important findings in: - Vital signs, including blood pressure, body temperature, and pulse rate - Electrocardiogram - Laboratory: haematology, hepatobiliary, clinical chemistry "

Countries

France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026