Back to resultsRZL-012 for Dercum's Disease Lipomas
Primary Purpose
Dercum's Disease Lipomas
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RZL-012
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dercum's Disease Lipomas
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Limitless Therapeutics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RZL-012
Vehicle of RZL-012
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Efficacy - Change in lipomas dimensions
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
Secondary Outcome Measures
Key secondary outcome - efficacy - Improvement in pain assessment of individual lipomas
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
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.
Full Information
NCT ID
NCT04229030
First Posted
January 9, 2020
Last Updated
February 23, 2021
Sponsor
Raziel Therapeutics Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04229030
Brief Title
RZL-012 for Dercum's Disease Lipomas
Official Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raziel Therapeutics Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dercum's Disease Lipomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RZL-012
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Vehicle of RZL-012
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RZL-012
Intervention Description
small synthetic molecule for the treatment of Dercum's Disease lipomas
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
placebo
Intervention Description
Vehicle of RZL-012 drug product
Primary Outcome Measure Information:
Title
Efficacy - Change in lipomas dimensions
Description
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
Time Frame
0-84 days
Secondary Outcome Measure Information:
Title
Key secondary outcome - efficacy - Improvement in pain assessment of individual lipomas
Description
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
Time Frame
0-84 days
Title
Safety change from baseline in clinical laboratory tests
Description
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.
Time Frame
0-28 days
Other Pre-specified Outcome Measures:
Title
Exploratory
Description
Improvement in Quality of Life - QOL questionnaire. Improvement will be measured for active vs. placebo at Day 0 and Day 84 following treatment.
Time Frame
0-84 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Limitless Therapeutics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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RZL-012 for Dercum's Disease Lipomas
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