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LGD-4665

Phase 2

Immune Thrombocytopenic Purpura | Small molecule | Hematology |GSK plc|Last Updated: Dec 16, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

LGD-4665 · 1 trial · 1 indication

Phase 2 1
NCT00621894Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment ContinuationImmune Thrombocytopenic Purpura
COMPLETED23 Analytics
PHASE2COMPLETED
Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation
Immune Thrombocytopenic PurpuraUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with platelet count >= 50000/µL
At Week 6

Response was defined as platelet count \>= 50 x1000/uL for participants without Baseline steroid uses; or platelet counts \>= 50 x1000/uL and doubling the Baseline platelet counts for participants with baseline steroid uses. Confidence interval of response rate was computed using exact method of binomial proportion.

Secondary Endpoints

Number of participants with time to response by Platelet Counts (platelet counts >= 50,000/µL)
Week 1, 2, 4 and 6 of part 1
Change From Baseline to Last Bleeding Observation During Double-Blind Treatment
Day 1 (Baseline) and Week 6
Duration of platelet counts >= 50,000/µL of LGD4665
Up to Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LGD4665EXPERIMENTALLGD-4665: Experimental Thrombopoietin mimetic
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
LGD-4665DRUGLGD-4665 Thrombopoietin mimetic
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Adults 18 years or older * Diagnosis of ITP for at least 3 months consistent with ASH guidelines * Treated with one or more prior therapies for ITP and platelet counts \< 30,000/µL or \< 50,000/µL if on a stable oral corticosteroid for ≥ 4 weeks, supported by 2 platelet counts...

Countries:United States
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Frequently asked questions about LGD-4665

What is LGD-4665 used for?

LGD-4665 is an investigational small molecule being studied for the treatment of immune thrombocytopenic purpura (ITP), a condition characterized by low platelet counts. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes LGD-4665?

LGD-4665 is being developed by GSK plc, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for immune thrombocytopenic purpura.

What phase is LGD-4665 in?

LGD-4665 is in Phase 2 clinical development. It is an investigational drug being evaluated for immune thrombocytopenic purpura (ITP) and has not received regulatory approval. One Phase 2 trial has been completed.

What clinical trials is LGD-4665 in?

LGD-4665 has been studied in one completed Phase 2 clinical trial, identified as NCT00621894. This trial evaluated oral LGD-4665 versus placebo in adults with immune thrombocytopenic purpura (ITP) over six weeks, with an open treatment continuation phase.

Is LGD-4665 FDA approved?

LGD-4665 is not FDA approved. It is an investigational drug in Phase 2 clinical development for immune thrombocytopenic purpura (ITP). The completed trial NCT00621894 assessed its safety and efficacy, but the drug remains unapproved.