A Phase 2 interventional study of LGD-4665 and Placebo in Immune Thrombocytopenic Purpura, sponsored by GlaxoSmithKline. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety parameters will be done weekly. All patients are eligible to continue on active, open LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each patient.
This is a Phase IIA study with two parts to the design.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory results within normal range except for the following analytes
Exclusion criteria:
Listed medications dosed within:
4 weeks of the first dose of the study treatment:
2 weeks of the first dose of the study treatment:
1 week of the first dose of the study treatment:
3 days of the first dose of the study treatment
LGD-4665: Experimental Thrombopoietin mimetic
Drug: LGD-4665
Placebo
Drug: Placebo
LGD-4665 Thrombopoietin mimetic
Placebo
Percentage of participants with platelet count >= 50000/µL
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.
Time frame: At Week 6
Number of participants with time to response by Platelet Counts (platelet counts >= 50,000/µL)
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.
Time frame: Week 1, 2, 4 and 6 of part 1
Change From Baseline to Last Bleeding Observation During Double-Blind Treatment
ITP Bleeding Severity Scale was used for the analysis of bleeding score. Bleeding scores were, 0=None, 1=minor, and 2=major. Body sites and bleeding grade analysis was as follows: cutaneous (1= 1-5 bruises; scattered petechiae and 2= \> 5 bruises, \>2 centimeter \[cm\]; petechiae), oral mucosa (1= 1 blood blister or \> 5 petechiae, gum bleeding \< 5 minute\[min\], 2= multiple blood blisters; gum bleeding \> 5 min), epistaxis (1= blood on blowing nose or epistaxis \< 5 min, 2= bleeding \> 5 min), gastrointestinal (1= occult blood, 2= gross blood), gynecological (1= spotting not at time of period, 2= bleeding not at time of period or very heavy period), urinary (1= microscopic (+ by dipstick), 2= macroscopic), pulmonary(1= possible symptoms but mild, 2= yes), subconjunctival (1= yes, 2= both eyes significantly involved), Intracranial (1= possible symptoms, 2= yes, clinically confirmed). Change from Baseline was calculated as Baseline value minus post-randomization value. Baseline was Day 1value.
Time frame: Day 1 (Baseline) and Week 6
Duration of platelet counts >= 50,000/µL of LGD4665
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.A Kaplan-Meier projection of time to response by platelet counts was analyzed.
Time frame: Up to Week 6
Plan to share: No — GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline