A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dā¦ (NCT06303570) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas
United States19 participantsStarted 2024-11-27
Plain-language summary
This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.
Who can participate
Age range18 Years ā 64 Years
SexALL
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Inclusion criteria
ā. Male or female, aged 18 years to 64 years old (at screening), inclusive.
ā. Body mass index (BMI) \>18.5 kg/m2 at screening and Day 1.
ā. Has confirmed DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator.
ā. Chronic pain (\>3 months) in the adipose tissue specific to the presence of lipomas and/or
ā. Pain in and around multiple lipomas.
ā. Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ā„10 mm and ā¤50 mm as measured by ultrasound (read by the Investigator) at screening.
ā. Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation.
ā. Voluntarily signs the informed consent form (ICF) and, in the opinion of the Investigator or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
Exclusion criteria
ā. Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
What they're measuring
1
To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD.