Clinical trial NCT06568042: Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuropathic Pain
Distal Sensory Polyneuropathy
Keywords: Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy
HIV Induced Peripheral Neuropathy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.

Participation may last up to 30 weeks including screening.


Eligibility criteria: Inclusion Criteria:

* Have a Visual Analog Scale (VAS) pain value ≥40 and \<95 at screening.
* Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.
* Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Other etiologies of pain that may not be due to DSP or confound the assessment due to painful DSP.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.
* Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin A1c (HbA1c) \>11% at screening.
* Cancer within 2 years of baseline, except for:

  * cutaneous basal cell or squamous cell carcinoma resolved by excision, or
  * cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a surgery planned during the study for any reason.
* History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.

Primary outcomes:
measure: Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in Pain Interference with Sleep
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity
timeFrame: Baseline, Week 12
measure: Mean Overall Improvement as Measured by Patient's Global Impression of Change
timeFrame: Week 12
measure: Use of Rescue Medication
timeFrame: Baseline up to Week 12
measure: Pharmacokinetic (PK): Serum Concentration of LY3848575
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research - Chandler
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Largo
country: United States
facility: Accel Research Sites - St. Pete-Largo Clinical Research Unit
state: Florida
city: Miami Lakes
country: United States
facility: Design Neuroscience Center
state: Florida
city: Orlando
country: United States
facility: Conquest Research - Orlando
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: Richmond
country: Canada
facility: Richmond Clinical Trials
state: British Columbia
city: Courtice
country: Canada
facility: Med Trust Research
state: Ontario
city: Guelph
country: Canada
facility: Dawson Clinical Research Inc.
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Network
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Montreal
country: Canada
facility: Genge Partners
state: Quebec
city: Ceske Budejovice
country: Czechia
facility: MUDr. Alena Vachova
state: Jihočeský Kraj
city: Ostrava
country: Czechia
facility: MUDr. Miroslav Koliba s.r.o.
state: Ostrava Město
city: Pilsen
country: Czechia
facility: NEUROS s.r.o.
state: Plzeň-město
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Praha 5
country: Czechia
facility: Praglandia s.r.o
city: Boeblingen
country: Germany
facility: Studienzentrum Dr. Bischof GmbH
state: Baden-Württemberg
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West
state: Niedersachsen
city: Siegen
country: Germany
facility: ZNS Siegen
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: emovis GmbH
city: Kasugai
country: Japan
facility: Kamezawa Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Kojunkai Daido Hospital
state: Aichi
city: Maebashi
country: Japan
facility: Kikuchi Naika Clinic
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Chugoku Central Hospital
state: Hiroshima
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Higashiibaraki
country: Japan
facility: Mito Medical Center
state: Ibaraki
city: Matsumoto
country: Japan
facility: Aizawa Hospital
state: Nagano
city: Saku
country: Japan
facility: Asama General Hospital
state: Nagano
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan
state: Saga
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Ootaku
country: Japan
facility: Medical Corporation Sato Medical clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Oita
country: Japan
facility: Fujigaki Clinic
city: Osaka
country: Japan
facility: Minamiosaka Hospital
city: Tokyo
country: Japan
facility: Niwa Family Clinic
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Kwangju-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
state: Jalisco
city: Morelia
country: Mexico
facility: Cicmex Centro de Investigación Clínica de México
state: Michoacán
city: Cuernavaca
country: Mexico
facility: Investigación Clínica Cuernavaca, S.C.
state: Morelos
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: Juriquilla
country: Mexico
facility: Health Pharma Querétaro
state: Querétaro
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne NEUROMED
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
state: Wielkopolskie
city: Lodz
country: Poland
facility: Santa Familia PTG Lodz
state: Łódzkie
city: Katowice
country: Poland
facility: Neuro-Care Sp. z o.o. sp. kom.
state: Śląskie
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: