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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
25/02/2020
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] 300209 0
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 315767 0
Condition category
Condition code
Skin 314052 314052 0 0
Other skin conditions
Cardiovascular 314530 314530 0 0
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] 316482 0
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] 322867 0
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] 322867 0
There is a single timepoint of 12 weeks from the first loading dose and ulcer biopsy taken at baseline stage.
Secondary outcome [1] 378604 0
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] 378604 0
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] 380070 0
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] 380070 0
there is a single timepoint of 12 weeks from baseline
Secondary outcome [3] 380071 0
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] 380071 0
There is a single timepoint of 12 weeks from baseline
Secondary outcome [4] 380073 0
Time to ulcer healing using visual assessment, digital photography, medical records and measuring device.
Timepoint [4] 380073 0
There is a single timepoint of 12 weeks from baseline
Secondary outcome [5] 380074 0
Percentage and absolute reduction in Pain score (0-10) using VAS pain scale
Timepoint [5] 380074 0
There is a single timepoint of 12 weeks from baseline
Secondary outcome [6] 380075 0
Changes in Quality of life DLQI score
Timepoint [6] 380075 0
There is a single timepoint of 12 weeks from baseline
Secondary outcome [7] 380076 0
Compliance with compression. This will be patient reported and visually assessable. (Compression bandaging intact or not intact at time of reviews)
Timepoint [7] 380076 0
There is a single timepoint of 12 weeks from baseline

Eligibility
Key inclusion criteria
1. Aged 18 years or older.

2. Patients who are willing to read or comprehend and sign a
voluntary consent for research

3. Patients with Chronic Venous Ulcers that have failed to
respond to Standard Therapy including Compression for
4 weeks
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Arterial insufficiency: Ankle-Brachial pressure index <0.7

2. Diabetes

3. Pregnancy

4. Crohn’s Disease

5. Ulcerative Colitis

6. Infection or excessive colonization of ulcer in past 2 months

7. Patients whose neutrophil count is not WNL

8. Patients who have active Tuberculosis (positive QFT-G)

9. Patients currently being treated for malignancy

10. Patients with chronic or recurrent candidiasis infection

11. Patients who have inflammatory bowel disease (IBD)

12. Women of childbearing age

13. Any contraindication to therapy

14. Life expectancy of less than 6 months due to chronic illness

Any other condition as defined by the investigator which significantly impact the
patient’s suitability in this study such as the use of cytotoxic medication, inability to
present to study visits due to distance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation controlled by the holder of the allocation schedule on site of trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Estimated number of 28 patients in 2 equal groups gives an 85% power at a significance level of 0.05 to detect an improvement of 40% in wound healing rates at 12 weeks (20% standard deviation). Based on preclinical studies, a 50% improvement is expected.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15802 0
Queensland Institute of Dermatology - South Brisbane
Recruitment postcode(s) [1] 29236 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304641 0
Commercial sector/Industry
Name [1] 304641 0
Eli Lilly Australia Pty Limited
Address [1] 304641 0
112 Wharf Road
West Ryde
NSW 2114
Australia
Country [1] 304641 0
Australia
Primary sponsor type
University
Name
The University of Queensland Diamantina Institute
Address
Level 6
Transitional Research Institute
37 Kent Street
Woolloongabba
Queensland
4102
Country
Australia
Secondary sponsor category [1] 304953 0
None
Name [1] 304953 0
Address [1] 304953 0
Country [1] 304953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305061 0
Human Research Ethics Metro South Brisbane
Ethics committee address [1] 305061 0
Human Research Ethics Department
Level 7 Transitional Research Institute
37 Kent Street
Woolloongabba
Brisbane
Queensland
4102
Ethics committee country [1] 305061 0
Australia
Date submitted for ethics approval [1] 305061 0
03/12/2019
Approval date [1] 305061 0
16/01/2020
Ethics approval number [1] 305061 0
HREC/2019/QMS/56565

Summary
Brief summary
The purpose of this study is to see if the medication ixekizumab might be used to treat underlying inflammation associated with chronic venous ulcers.

The study is for anyone with a chronic venous ulcer that has failed to respond to standard therapy (compression bandaging for four consecutive weeks).

28 patients are required for this trial. 14 patients will receive the treatment medication and 14 will receive the placebo medication. Neither the patients nor the staff will know who is receiving which medication.

You will receive injections fortnightly for 12 weeks including continuing with the dressings and compression bandaging that you were being treated with prior to the trial.
After the 12 weeks it is hoped that this medication Ixekizumab will have added in a significant reduction in the wound size.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99134 0
Prof Kiarash Khosrotehrani
Address 99134 0
Experimental Dermatology Group Leader
The University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Australia


Country 99134 0
Australia
Phone 99134 0
+61 7 344 37088
Fax 99134 0
+61 7 344 36966
Email 99134 0
k.khosrotehrani@uq.edu.au
Contact person for public queries
Name 99135 0
Ms Kirsty Fry
Address 99135 0
The University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Australia


Country 99135 0
Australia
Phone 99135 0
+61 7 344 37088
Fax 99135 0
+61 7 344 36966
Email 99135 0
k.fry@uq.edu.au
Contact person for scientific queries
Name 99136 0
Prof Kiarash Khosrotehrani
Address 99136 0
Experimental Dermatology Group Leader
The University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Australia


Country 99136 0
Australia
Phone 99136 0
+61 7 344 37088
Fax 99136 0
+61 7 344 36966
Email 99136 0
k.khosrotehrani@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6793 0
Ethical approval
Citation [1] 6793 0
Link [1] 6793 0
Email [1] 6793 0
Other [1] 6793 0
Type [2] 6794 0
Study protocol
Citation [2] 6794 0
Link [2] 6794 0
Email [2] 6794 0
Other [2] 6794 0
Type [3] 6795 0
Informed consent form
Citation [3] 6795 0
Link [3] 6795 0
Email [3] 6795 0
Other [3] 6795 0
Summary results
No Results