Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)

NCT07072468 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: VMT-03C1191061011031
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral neuropathy is a disorder caused by damage to the peripheral nerves. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain chemotherapy drugs, such as platinum-based compounds, taxanes, and vinca alkaloids, which can damage nerve fibres by disrupting their structure and function. At present, relief of neuropathic pain in CIPN is limited, and existing therapies providing only modest and variable efficacy across patients. This is a study of VMD-3866 gel (the study medicine which is non-opioid, non-NSAID), an experimental new topical medicine for treating pain caused by CIPN. The goal of this study is to assess if the study medicine improves pain symptoms in patients with CIPN, and to find out the side effects of the study medicine if any. The study medicine will work by selectively blocking a specific sub-type of proteins (called T-type calcium channels) in the nerves under the skin which will lower the activity of the nerves and therefore reduce pain. It is a topical gel, meaning that it is applied to the skin, and its novel gel formulation limits that only little amount of study medicine may enter the blood and none enters the brain. This means it's unlikely to be addictive and it's unlikely to have any impact on participant current medications. Researchers will compare study medicine to a matching placebo (a look-alike gel that contains no drug) to see if VMD-3866 gel works to management of pain caused by CIPN.

Conditions

Drug-Induced Nephropathy; Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy-Induced Peripheral Neuropathy; Chemotherapy-Induced Peripheral Neuropathic Pain; Neuropathic Pain; Chronic Pain; Nephropathy; Tingling; Numbness; Burning; Drug-Induced Nephropathy

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the sum of daily numeric pain rating scale (NPRS) score at the end of each treatment period.

  The participants assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.

  Daily for 8 days for each of 2 treatment periods, up to 1 month in total

• Number of participants with an Adverse Event (AE).

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AE(s) in each period will be reported.

  Daily for 8 days for each of 2 treatment periods, up to 1 month in total

Secondary Outcomes (6)

• Change from baseline in average daily NPRS score, and the proportion of participants with at least 30% and 50% reductions

  Daily for 8 days for each of 2 treatment periods, up to 1 month in total

• Change from baseline in the short-form McGill Pain Questionnaire 2 (SF-MPQ-2)

  Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total

• Change from baseline in weekly sleep interference scores assessed with Pain and Sleep Questionnaire three-item index (PSQ-3)

  Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total

• Patient global impression of change (PGIC)

  Day 8 for each of 2 treatment periods, up to 1 month in total

• Frequency of use and dose of rescue medication during treatment period

  Daily for each of 2 treatment periods, up to 1 month in total

Study Arms (2)

VMD-3866 Gel

EXPERIMENTAL

Treatment Group

Drug: VMD-3866 Gel

Placebo Gel

PLACEBO COMPARATOR

Placebo Group

Drug: Placebo Gel

Interventions

VMD-3866 Gel DRUG

Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record NPRS scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose). Participants will be screened within 45 days before their first treatment period. Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home.

VMD-3866 Gel

Placebo Gel DRUG

Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record NPRS scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose). Participants will be screened within 45 days before their first treatment period. Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home.

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient who has received any type of chemotherapy treatment for cancer and are in remission.
• Participants must be diagnosed with CIPN and must be showing moderate (Grade 2, as defined by the Common Terminology Criteria for Adverse Events) symptoms of peripheral sensory neuropathy, including pain and hypersensitivity, for ≥ 3 months. Participants must have had stable symptoms of CIPN for 8 weeks before screening. Participants with any other conditions associated with neuropathy, or conditions which might confound pain assessment (e.g. other severe pain or a skin condition in the area affected by neuropathy) will be excluded.
• Aged 18-80 years (inclusive) at the time of consent.
• Mean daily pain score of 4-8 on the 11-point NPRS, for at least 4 days during Run-in 1.
• A score of 0 or 1 on the ECOG Performance Status Scale.
• Capable of self-administering topical VMD-3866 or placebo gel to the designated treatment area(s).
• Capable of understanding the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
• Agrees to take only the allowed rescue medication (paracetamol) for breakthrough pain, from screening and throughout the study.
• Willing to give written consent to participate after reading the informed consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
• Agrees to follow the contraception requirements of the trial.
• Agrees not to donate blood or blood products during the trial and for up to 3 months after the administration of the trial medication.

You may not qualify if:

• Woman who is pregnant or lactating, or premenopausal woman who is sexually active and not using a reliable method of contraception.
• History of painful conditions not associated with CIPN (e.g. frequent headache) that require administration of paracetamol or non-steroidal anti-inflammatory drugs, more than twice a week.
• Presence of peripheral neuropathy of another etiology (e.g. alcohol, diabetes, toxins, neurotoxic treatments, hereditary, autoimmune).
• Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant.
• Clinical, history or previous laboratory evidence of significant conditions (e.g. diabetes, seizure or psychological conditions) that could interfere with completion of study procedures and assessments or pose an additional risk to the participant.
• Cardiovascular events (stroke, heart attack, pulmonary embolism) in the last 3 months.
• Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, dementia, bipolar disorder or schizophrenia spectrum disorder.
• History of suicide attempt, or suicidal ideation in the last 6 months.
• Presence of active and/or systemic infection, or history of severe infection during the 30 days prior to screening.
• Damaged or tattooed skin, active skin disease, infection, severe erythema, or any other compromise in integrity of skin at the designated treatment area(s), which could influence or interfere with the evaluation of the safety or efficacy of VMD-3866.
• Presence or history of severe adverse reaction(s) to any drug or a history of sensitivity to any excipients of VMD-3866.
• Participation in any studies for skin irritation or sensitization within the 30 days before first dose.
• If a skin biopsy is required: contraindications to skin biopsy (e.g. patients with significant bleeding tendencies or using anti-coagulants).
• Receipt of an investigational medicinal product (including prescription medicines and devices) as part of another clinical trial, in the 3 months before first dose or 5-half-lives (whichever is longer); or is in the follow-up period of another clinical trial at the time of screening for this trial.
• Use of topical capsaicin preparations (including Qutenza patch) in the 3 months before screening.

Sponsors & Collaborators

• VM Therapeutics LLC: lead

Study Sites (1)

Hammersmith Medicines Research Ltd (HMR code 24-503)

London, UK, NW10 7EW, United Kingdom

RECRUITING

Related Links

• HMR code 24-503; Safety and effectiveness of VMD-3866 in patients with CIPN (Protocol number VMT-03C)

MeSH Terms

Conditions

Neuralgia; Chronic Pain; Kidney Diseases; Paresthesia; Hypesthesia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Somatosensory Disorders; Sensation Disorders

Study Officials

• Clinical Development

  VM Therapeutics LLC

  STUDY CHAIR

Central Study Contacts

Jay Wu, PhD

CONTACT

+1 510 962 8100; om@vmtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 16 participants is planned. Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record numeric pain rating scale (NPRS) scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose). Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST (quantitative sensory test) and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home. At the end of each treatment period, participants will undergo QST assessment

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 18, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)