A Study in Patients with Hard-to-Heal Venous Leg Ulcers to Measure Efficacy and Safety of Locally Administered LL-37; A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial - HEAL LL-37

Promore Pharma AB0 sites159 target enrollmentJune 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

June 21, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Capable and voluntarily giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated written ICF must be prior to any mandatory study specific procedures, sampling and analyses.
•2\. Male or female \=18 years of age at the time of signing the ICF
•3\. Female patients must be 1 year post\-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) until the last dose of LL\-37/matching placebo to prevent pregnancy. In addition, approved contraceptive implant, long\-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
•4\. Negative pregnancy test (women of child\-bearing potential only)
•5\. Lower leg ulcers presumed to be caused by venous insufficiency
•6\. Target leg ulcer that has failed to heal within a minimum of 6 weeks of compression therapy
•7\. Ankle\-brachial pressure index (ABI) \>0\.70 at screening
•8\. Ulcer localisation above the foot and below the knee (ankle and malleoli included)
•9\. Surface area of target ulcer 2 to 40 cm2 at screening
•10\. Ulcer essentially free of necrotic tissue

•1\. Other known predominant aetiology than VLU of the target ulcer, such as trauma
•2\. Malignant disease (excluding basal cell carcinoma) unless in remission for 5 years
•3\. P\-albumin \<25 g/L or HbA1c \>10%
•4\. Presence of active psoriasis skin lesions within 1\.5 cm of the ulcer area
•5\. Ulcer which by location or extension is either difficult to assess or treat according to the protocol
•6\. Presence of a non\-study ulcer within 2 cm of the target VLU
•7\. Exposure of bone, tendon or fascia within the target ulcer
•8\. Clinical signs or symptoms of an infection of the target ulcer, erysipelas, or osteomyelitis requiring systemic antibiotic treatment
•9\. Systemic immunosuppressive drugs with the exception of low\-dose oral steroids: glucocorticoids corresponding to oral prednisolone \=10 mg/day are allowed provided that drug treatment has been initiated not earlier than 4 weeks prior to the screening visit and at that time point, is expected to be maintained at similar dose level throughout the study period. Also, mineral corticoids are permitted.
•10\. Known hypersensitivity to any component of the study drug or standard ulcer dressing allowed during study treatment period or follow\-up period