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ETX-018810

Phase 2

Lumbosacral Radiculopathy | Small molecule | Neurology |Climb Bio, Inc.|Last Updated: Nov 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment149

FDA Designations

No designations recorded

Clinical trial landscape

ETX-018810 · 2 trials · 3 indications

Phase 2 2
NCT04778592Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular PainLumbosacral Radiculopathy
COMPLETED149 Analytics
NCT04688671Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic Pain
COMPLETED167 Analytics
PHASE2COMPLETED
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Lumbosacral RadiculopathyUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)
Baseline to Week 4

Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

Secondary Endpoints

Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score
Baseline to Weeks 1, 2, 3 and 4
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score
Baseline to Weeks 1, 2, 3 and 4
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
Baseline to Weeks 1, 2, and 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ETX-018810EXPERIMENTALDrug: ETX-018810 BID for 4 weeks
PlaceboPLACEBO_COMPARATORMatching Placebo BID for 4 weeks

Interventions

NameTypeDescription
ETX-018810DRUGStudy Drug
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * The subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s) * The subject reports at least moderate pain intensity at screening. * The subject's onset of leg pain due to LSRP is at least 3 months * The su...

Countries:United States
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Frequently asked questions about ETX-018810

What is ETX-018810 used for?

ETX-018810 is an investigational small molecule being developed for the treatment of diabetic peripheral neuropathic pain and lumbosacral radiculopathy. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes ETX-018810?

ETX-018810 is being developed by Climb Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker CLYM.

What phase is ETX-018810 in?

ETX-018810 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in diabetic peripheral neuropathic pain and one in lumbosacral radiculopathy. The drug remains investigational and has not been approved.

What clinical trials has ETX-018810 been in?

ETX-018810 has been studied in two completed Phase 2 trials. NCT04688671 evaluated the drug in 167 patients with diabetic peripheral neuropathic pain, and NCT04778592 evaluated it in 149 subjects with lumbosacral radicular pain. Both trials were conducted in the United States.

Is ETX-018810 the same as another drug?

ETX-018810 is the drug name used in clinical trials for this investigational small molecule. No other names for this drug have been reported.