Topical rVA576 for treatment of atopic keratoconjunctivitis: a randomised placebo double masked parallel trial (TRACKER)

Phase 1

Conditions: Moderate to severe atopic keratoconjunctivitis (AKC),Vernal keratoconjunctivitis (VKC),Severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC))
MedDRA version: 20.0Level: PTClassification code 10069664Term: Atopic keratoconjunctivitisSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 21.0Level: PTClassification code 10081000Term: Vernal keratoconjunctivitisSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 21.0Level: LLTClassification code 10081002Term: Vernal keratoconjunctivitis perennialSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: LLTClassification code 10001709Term: Allergic conjunctivitisSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2017-002835-40-ES

Lead Sponsor: Akari Therapeutics Plc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 19

Inclusion Criteria

Patients must meet the following criteria in order to be included in the study:
Inclusion Criteria:
1. Aged 18 and above
2. Diagnosis of moderate to severe AKC, VKC, or severe allergic conjunctivitis (seasonal or perennial). Defined as:
• AKC, VKC - a composite symptom/sign score from one eye of = 18 out of 33 (see Clinical Scoring Section 17.1)
• Severe allergic conjunctivitis (SAC or PAC) - a composite symptom/sign score from one eye of = 15 out of 27 (see Clinical Scoring Section 17.2)
3. Will have had received some topical therapy during the last 3 months without improvement but will not currently be receiving systemic immunotherapy. Topical therapy may be topical cyclosporin, antihistamines or corticosteroids alone or in combination. Lubricants or artificial tears will not a count as topical therapy for these purposes.
4. Will have had at least 7 days without topical ocular corticosteroids prior to entry
5. Willing to give informed consent
6. Willing to use highly effective contraceptive precautions for the duration of the study and for 90 days after the last dose of IMP
7. Willing to avoid prohibited medications for duration of study (see list of prohibited medications)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

A patient will not be eligible for the study if he/she meets one or more of the following criteria:
Exclusion Criteria:
1. Eye surface disease other than AKC, VKC or severe allergic conjunctivitis (SAC or PAC)
2. Contact lens use during the study
3. Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination
4. Ankyloblepharon of any degree at entry to the trial
5. Known or suspected ocular malignancy
6. Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs
7. Known or suspected uveitis
8. Participation in any other clinical trial within 1 month of enrolment
9. Use of any of the following prohibited medications:
• Eculizumab
• Any other investigational complement inhibitor whether systemic or topical (e.g. RA101495)
• Montelukast
• Zafirlukast
• Pranlukast
• Zileuton
• Hypericum perforatum (St John’s wort)
10. Corneal perforation
11. Uncontrolled glaucoma (increase in dose of glaucoma medication or surgical intervention for glaucoma within 3 months prior to entry)
12. Pregnancy (females)
13. Breast feeding (females)
14. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
15. Use of topical ocular steroids within 7 days of the Screening visit
16. Failure to satisfy the PI of suitability to participate for any other reason

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective of the study is to assess the efficacy (how well it works) of topical rVA576 in patients with moderate to severe atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC) and severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC));Primary end point(s): Incidence of ocular treatment emergent adverse events during the treatment period (adverse events which have occurred during the 56 days following randomisation (Part 2 of the study only) will be considered in the analysis of the primary safety outcome).;Main Objective: The primary objective of the study is to assess safety and tolerability (how well the patient copes with the drug) of topical rVA576 for patients with moderate to severe atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC) and severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC));Timepoint(s) of evaluation of this end point: Evaluations at Day 1, 14, 28, 42, 56 and 84.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Endpoints will include:<br>• Post-instillation comfort, as graded on patient diary cards at the following intervals Days 1-14, Day 15-28, Day 29-42 and Day 43-56<br>• Visual acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) charts comparison from Day 1 to Day 56<br>• Change from Day 1 in composite clinical scores at Day 14, 28, 42 and 56<br>• Number and percentage of patients with MMP-9 positive levels at Days 1, 28 and 56<br>• Change from Day 1 in Tear film break up time (TBUT) at Day 14, 28, 42 and 56;Timepoint(s) of evaluation of this end point: Evaluations at Day 1, 14, 28, 42 and 56

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