A Phase 2a, Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of CBL-514 Injection for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite (Stage 2)
Overview
- Phase
- Phase 2
- Intervention
- CBL-514 injection
- Conditions
- Cellulite
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Enrollment
- 23
- Locations
- 5
- Primary Endpoint
- Evaluation of the score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.
Detailed Description
This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2. The Stage 2 will include a total of 20 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female aged 18 years to 64 years old (at Screening), inclusive.
- •Have a BMI \> 18.5 and \< 35 kg/m2 and body weight ≥ 50 kg at Screening and Day
- •The participant has both sides of posterolateral thighs assessed according to the modified Hexsel CSS (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. On assessment by the modified Hexsel CSS, the participant scores at least 4 and no greater than 8 at Screening and Day
- •The total score must contain:
- •Hexsel CSS item (A) 'number of evident depressions' score of ≥1
- •Hexsel CSS item (B) 'depth of depressions' score of ≥ 1
- •Participant has a stable lifestyle (e.g., exercise, eating patterns, and smoking habit) per participant report for at least 3 months before Screening and during the study.
- •Voluntarily signs the informed consent form and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
Exclusion Criteria
- •Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen with her partner from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Note: females who are not of childbearing potential are not required to use contraception. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (defined as aged at least 50 years old with ≥ 12 months of amenorrhea and a follicle-stimulating hormone \[FSH\] \> 30 IU/L at Screening).
- •Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation within 14 days prior to the IP administration.
- •Participant has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of the Investigator (or designee) is inappropriate to participate in the study.
- •Participant has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG) at Investigator's (or designee's) discretion.
- •Participant with active or prior history of malignancies within 5 years before Screening or being assessed for a possible malignancy. Except adequately treated basal cell carcinoma of the skin and in situ squamous cell carcinoma of the skin would be eligible as per Investigator's (or designee's) discretion.
- •Participant with a history of human immunodeficiency virus (HIV)-1 infection, or participants with active HIV infection at Screening with a positive HIV antigen/antibody (Ag/Ab) combination test.
- •Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and pass out at the sight of blood or a needle.
- •Participant with any hepatic medical condition that, in the opinion of the Investigator (or designee), would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or provide informed consent.
- •Participant who has a recent history of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication within 6 months prior to Screening.
- •Participant has abnormal skin or local skin conditions at the treatment area, which in the opinion of the Investigator (or designee), is inappropriate to participate in the study. This includes but is not limited to any of the following:
Arms & Interventions
CBL-514 up to 320mg
Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Intervention: CBL-514 injection
Outcomes
Primary Outcomes
Evaluation of the score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.
Time Frame: 4 weeks from the final treatment visit
Change in total scores from baseline according to the modified Hexsel CSS at V4 based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations following administration of at least 1 course of CBL-514. (A) Number of evident depressions: '0' = None/no depressions '1' = 1 to 4 depressions are visible '2' = 5 to 9 depressions are visible '3' = 10 or more depressions are visible (B) Depth of depressions: '0' = No depressions '1' = Superficial depressions '2' = Medium depth depressions '3' = Deep depressions (C) Morphological appearance of skin surface alterations: '0' = No raised areas '1' = 'Orange peel' appearance '2' = 'Cottage cheese' appearance '3' = 'Mattress' appearance The total score of (A), (B) and (C) will determine the cellulite severity level as follows : 0 = None 1-3 = Mild 4-6 = Moderate 7-9 = Severe
Secondary Outcomes
- Evaluation of the response rate of EFP score change by Global Aesthetic Improvement Scale (GAIS) reported by the clinician and participant, respectively, following the administration of at least 1 course of CBL-514.(Up to 12 weeks from the final treatment visit)
- Percentage of participants' thighs that achieve at least 2-score improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.(Up to 12 weeks from the final treatment visit)
- Percentage of participants' thighs that achieve at least 1-level severity improvement measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.(Up to 12 weeks from the final treatment visit)
- Evaluation of the total score change of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of at least 1 course of CBL-514.(12 weeks from the final treatment visit)