Clinical trial NCT05322525: A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.
Official title: A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Leg Ulcers (VLU)
Keywords: ON101
Fespixon
Venous leg ulcers
C6 or C6R
Lead sponsor: Oneness Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Taipei Medical University Shuang Ho Hospital
First posted: 2022-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.
Primary purpose: OTHER

Brief summary: A Research Study to evaluate the safety and potential efficacy of ON101 cream for the treatment of venous leg ulcers.The objectives of the study are to determine the safety and to explore the potential efficacy of ON101 cream in patients with venous leg ulcers.

Detailed description: This is a multi-center, open-label study to investigate the Safety and Potential Efficacy of ON101 Cream in Venous Leg Ulcers (VLU) patients. Subjects with VLU of CEAP C6 (active venous ulcer) or C6R (recurrent active venous ulcer) are to be included in this study. If a subject has more than one ulcer on the leg, the most severe ulcer then the largest ulcer that confirm to meet the eligibility criteria will be selected for study evaluation.

12 eligible subjects will be enrolled and receive ON101 cream treatment. Enrolled subjects will be instructed to apply the study treatment on the selected target ulcer for a maximum of 18 weeks, until the ulcer complete closure (ulcer size of 0) for two consecutive visits that at least 2 weeks apart, or until the subject exit the study prematurely due to any reason. Identical standard of care (SoC) procedure will be performed in both the control and investigational product arms throughout the study period, which including ulcer cleansing, debridement if necessary, and application of a suitable dressing and compression system until complete ulcer closure. Subjects are required to apply compression device at least 8 hours per day throughout the treatment period.

The study consists of three periods, a 2-week Screening/Run-in period, an up-to-18-week Treatment period, and a 1-to-2-week Follow-up period. The Screening/Run-in period is to ensure the subjects' eligibility and their compliance to compression therapy and to exclude subjects who demonstrate substantial healing resulting solely from improved compliance with SoC. The Treatment period is to determine the safety and to explore the potential efficacy of the study product. The Follow-up period is to assess the safety. During the Follow-up period, SoC will be provided to subjects with non-healing or recurrent target ulcer.

Eligibility criteria: Inclusion Criteria:

1. Has signed a written informed consent prior to the study procedure
2. Male or female aged at least 20 years old
3. Venous outflow/venous capacitance (VO/VC) compatible with venous insufficiency measured at screening visit or within 3 months prior to enrollment
4. Has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3 measured at screening visit or within 3 months prior to enrollment
5. The target ulcer have all of the following characteristics:

   1. C6 or C6R per the Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) Classification System;
   2. Located between the knee and ankle (at or above the malleolus);
   3. No active infection;
   4. Post debridement ulcer area is ≥ 3 cm2 and ≤ 20 cm2 at the time of enrollment;
   5. Has been presented for at least 6 weeks before enrollment;
   6. A minimum of 2 cm margin between the qualified target ulcer and any other ulcers on the target limb (post debridement);
   7. Involves a full thickness skin loss, but without exposure of tendon, muscle, or bone;
   8. Must be nonhealing as defined as ≤ 30% reduction in ulcer area in response to standard of care (SoC) during the 2-week run-in period
6. Considered by the Investigator to be compliant/adhere to the compression device during the 2-week run-in period
7. If female of child-bearing potential, has a negative pregnancy test on urine at screening and must not be breastfeeding
8. Able and willing to attend the scheduled visits and comply with the study procedures.

Exclusion Criteria:

1. Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
2. With deep vein thrombosis within 4 weeks prior to enrollment
3. Has endovenous surgery planned or performed within 4 weeks prior to enrollment
4. Laboratory values at Screening of:

   1. Liver function test (total bilirubin, aspartate aminotransferase \[AST\], or alanine aminotransferase \[ALT\]) \&gt; 3x the upper limit of normal, or
   2. Poor nutritional status defined as albumin \&lt; 2.5 g/dL, or
   3. Renal function test (serum creatinine) \&gt; 2x the upper limit of normal, or
   4. Glycosylated hemoglobin (HbA1c) ≥ 9 %
5. Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the Investigator, could interfere with ulcer healing, including but not limited to the following:

   1. Systemic infection not controlled by suitable antibiotic treatment
   2. Active malignant disease. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, maybe considered for study entry.
   3. Acquired immune deficiency syndrome (AIDS) or HIV positive
6. Has received treatment with immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to enrollment
7. Heavy smoker (≥ 20 cigarettes per day)
8. Use of any investigational drug or therapy within 4 weeks prior to enrollment
9. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which in the opinion of the Investigator, may pose a threat to subject compliance
10. Judged by the Investigator to be not suitable for study participation

Primary outcomes:
measure: Safety endpoint(1) : Treatment-Emergent Adverse Event
timeFrame: Through study completion, an average of 6 months
measure: Safety endpoint(2-1) : Change from baseline in vital signs
timeFrame: Through study completion, an average of 6 months
measure: Safety endpoint(2-2) : Change from baseline in physical examination
timeFrame: Through study completion, an average of 6 months
measure: Safety endpoint(2-3) : Change from baseline in laboratory test
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Efficacy endpoint(1): ulcer healing time measured
timeFrame: Through study completion, an average of 6 months
measure: Efficacy endpoint(2): complete healing of the target ulcer
timeFrame: Through study completion, an average of 6 months
measure: Efficacy endpoint(3): change from baseline in the target ulcer area
timeFrame: Through study completion, an average of 6 months
measure: Efficacy endpoint(4): percentage change from baseline in the target ulcer area
timeFrame: Through study completion, an average of 6 months
measure: Efficacy endpoint(5): between target ulcer area and time to complete ulcer healing
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Oneness Biotech Co., Ltd.
name: Shyi-Gen Chen, MD
role: STUDY_DIRECTOR
References: