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NCT02000440 · ClinicalTrials.gov registry record · Phase 2

A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target

NCT02000440: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT02000440 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02000440, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive proteinuria as indicated by a Urinary protein/creatinine Up/c ratio \>=2 gram/gram (g/g) or 24 hr urine protein \>=2 g/day. Losmapimod will be orally administered twice daily over a 24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments.

Primary Outcome

Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as a responder on achieving \>=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of \>=70 percent of Baseline estimated glomerular filtration rate (eGFR) at end of treatment (\>=16 Weeks). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Interventions

  • DRUG Losmapimod

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2014-07-01
Est. Completion 2016-05-11
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT02000440 record still lists

NCT02000440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which Losmapimod is the first listed.

NCT02000440 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02000440 about?

NCT02000440 is a clinical study titled "A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)". This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive proteinuria as indicated...

What is the current status of trial NCT02000440?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2014-07-01. Estimated completion is 2016-05-11.

What interventions are being tested in trial NCT02000440?

The interventions under investigation include: Losmapimod (DRUG).

Who is sponsoring clinical trial NCT02000440?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02000440's enrollment target sits among peer trials

17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02000440, the US trial registry maintained by the National Library of Medicine. NCT02000440 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.