Thirty-eight (38) subjects will be included in the study. Subjects will be randomized in a ration of 1:1 to be treated with RZL-012 or placebo. Subjects will be injected with a different doses of RZL-012 according to their lipomas sizes. The total of 38 subjects will be enrolled in 3 clinical sites.
Full Title of Study: “A Double Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2B Clinical Trial for the Evaluation of Efficacy and Safety of RZL-012 in Subjects Having Dercum’s Disease Lipomas”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 31, 2021
This is a multi-center, randomized, double blind, placebo controlled clinical trial in DD subjects having lipomas. Subjects will be randomized, in a 1:1 ratio, into two groups injected with either RZL-012 or vehicle.
Once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will be offered the option of receiving treatment with RZL-012 and followed up for an additional 84 days.
At least 4 lipomas/nodules, preferably 6, and no more than 8, will be injected per subject, two of which will be medium (4-5.9 cm), large (6-7.9 cm) or extra-large (8-10 cm) in diameter. Dosing will be according to lipoma size, where the total injected dose will not exceed 240 mg per patient (48 injections at 5mg/injection).
- Drug: RZL-012
- small synthetic molecule for the treatment of Dercum’s Disease lipomas
- Drug: Vehicle
- Vehicle of RZL-012 drug product
Arms, Groups and Cohorts
- Active Comparator: RZL-012
- A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL RZL-012 (5mg). Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL RZL-012 (20mg). 4-5.9 cm will be dozed with 0.8mL RZL-012 (80mg). 6-7.9 cm will be dozed with 1 mL RZL-012 (100mg). 8-10 cm will be dozed with 1.2 mL RZL-012 (120mg).
- Placebo Comparator: Vehicle of RZL-012
- A single-treatment injection, multiple subcutaneous injections of vehicle administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL vehicle. Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL vehicle. 4-5.9 cm will be dozed with 0.8mL vehicle. 6-7.9 cm will be dozed with 1 mL vehicle. 8-10 cm will be dozed with 1.2 mL vehicle.
Clinical Trial Outcome Measures
- Efficacy – Change in lipomas dimensions
- Time Frame: 0-84 days
- Evaluation of the efficacy of RZL-012 following injection into lipomas/nodules of Dercum’s Disease (DD) subjects. Efficacy will be determined by ultrasound assessment of the lipoma/nodule dimensions after treatment vs baseline. Lipomas Dimensions will be measured for active vs. placebo at days 28,56,84
- Key secondary outcome – efficacy – Improvement in pain assessment of individual lipomas
- Time Frame: 0-84 days
- Assessment of lipoma/nodule associated pain using the Comparative Pain Scale. 0 is “no pain” and 10 is “worst pain”. Pain measured for active vs. placebo at days 28,56,84
- Safety change from baseline in clinical laboratory tests
- Time Frame: 0-28 days
- Safety will be assessed by by change-from-baseline values for clinical laboratory tests. measured for active vs. placebo at days 1 and 28 following injection. Number of subjects with abnormal laboratory values will be compared in both study arms.
Participating in This Clinical Trial
- At least 4 painful lipomas of appropriate size to be injected on a background of Dercum's Disease.
- Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG) and laboratory evaluation with an emphasis on metabolic parameters (fasting glucose concentration < 200 mg/dL).
- Subjects must be able to adhere to the visit schedule and protocol requirements and be capable of completing the study.
- Males or females in the age of fertility are willing to refrain from sexual activity or agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
- Subjects must sign an informed consent indicating they are aware of the investigational nature of the study.
- Unable to tolerate subcutaneous injections.
- Pregnant women.
- Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator places the subject at significant risk.
- Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).
- Subjects with a clinical history of active primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids
- Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
- As a result of medical review and physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
- Known sensitivity to components of the injection formulation.
- Prior wound, tattoo or infection in the treated area.
- Prior invasive treatment such as surgery or injectable drug at the RZL-012 injected area.
- Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
- Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
- Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Raziel Therapeutics Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Karen Herbst, MD, Principal Investigator, Arizona
- Overall Contact(s)
- Racheli Gueta, PhD, 972-8-9126941, firstname.lastname@example.org
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