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ETX-018810

Phase 2

Diabetic Peripheral Neuropathic Pain | 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 Enrollment167

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 currently in Phase 2 clinical development and has not been approved by the FDA.

Who is developing ETX-018810?

ETX-018810 is being developed by Climb Bio, Inc., a biopharmaceutical company traded under the ticker CLYM. The company is conducting clinical trials to evaluate the drug's efficacy and safety for neurological pain conditions.

What phase is ETX-018810 in?

ETX-018810 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for diabetic peripheral neuropathic pain and one for lumbosacral radiculopathy. The drug remains investigational and is not yet 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 patients with lumbosacral radiculopathy. Both trials were conducted in the United States.

Is ETX-018810 the same as any other drug?

No alternative names for ETX-018810 have been disclosed. The drug is identified solely by its code name ETX-018810 in clinical trial registries and by its developer, Climb Bio, Inc.