ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000235909

Ethics application status

Approved

Date submitted

5/02/2020

Date registered

25/02/2020

Date last updated

1/11/2022

Date data sharing statement initially provided

25/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Trial of new medication Ixekizumab to assess healing of venous leg ulcers.

Scientific title

IxeHeal - Phase II Study of Ixekizumab for Chronic Venous Ulcers

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1247-7996

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Venous Ulcers

Condition category

Condition code

Skin

Other skin conditions

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Cohorts of patients with chronic venous ulcers (n = 28) will be randomly assigned to treatment and placebo groups, both receiving continuous compression treatment and standard dressing and therapy of wounds.
Ixekizumab or placebo will be injected subcutaneously (prefilled syringe format) in two 80 mg injection at week 0, followed by single 80mg injections at weeks 2, 4, 6, 8, 10 and 12. This corresponds to standard dosing regimen performed in psoriasis.

Standard dressings and compression bandaging will be removed, re-dressed and re-bandaged at each visit (fortnightly) by the nurse. Each dressing and bandage change will take approximately 30mins to complete.

Compression Treatment - bandaging to the leg applying as much compression as is tolerated by the patient. Every patient will have differing degrees of compression.
Standard Dressings - Dressings applied to the leg under the compression bandaging.
Therapy - If patients are receiving additional therapy such as regular wound cleaning.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Patients receiving placebo will be the comparators in this study.

Patients receiving the Placebo will receive the one injection containing the below excipients at 2,4,6,8,10 and 12 week intervals

The excipients listed below together make up a single placebo injection.

• sodium chloride 11.69 mg/mL
• sodium citrate dihydrate 5.11 mg/mL
• citric acid 0.51 mg/mL
• polysorbate 80 0.30 mg/mL
• water for injections

Control group

Placebo

Outcomes

Primary outcome [1]

Primary outcome will be to compare the proportion of patients achieving a 40% reduction in wound size between treatment and placebo groups using 3D digital photography and size evaluation device.

Biopsies and fluid taken from the ulceration tissue and site at baseline and 12 weeks to measure the amount of wound-infiltrating macrophage phenotypes that have changed from M1 to M2 and if there has been a treatment-related reduction of IL17 levels in wound fluid and biopsies.

Timepoint [1]

There is a single timepoint of 12 weeks from the first loading dose and ulcer biopsy taken at baseline stage.

Secondary outcome [1]

Drug related adverse events and serious adverse events.
Ixekizumab may increase the risk of infection such as upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea
Injection site reactions have been observed causing erythema and pain.
Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema and urticaria, have been reported.

Timepoint [1]

There is a single timepoint of 12 weeks for the review of any events that will be recorded on the Eli Lilly trial portal, patient records and reports.

Secondary outcome [2]

Percentage reduction in ulcer size at 12 weeks compared to the initial wound size using 3D digital photography, wound size evaluation device and biopsy results.
Biopsies and fluid taken from the ulceration tissue and site at baseline and 12 weeks to measure the amount of wound-infiltrating macrophage phenotypes that have changed from M1 to M2 and if there has been a treatment-related reduction of IL17 levels in wound fluid and biopsies.

Timepoint [2]

there is a single timepoint of 12 weeks from baseline

Secondary outcome [3]

Percentage patients with healed ulcers
A Consultant Dermatologist or Medical Research Assistant will visually assess the ulcers, there will not be a second biopsy taken if complete wound healing has occurred.

Timepoint [3]