Moderate to severe atopic keratoconjunctivitis (AKC), Vernal keratoconjunctivitis (VKC), Severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC)) MedDRA version: 20.0 Level: PT Classification code 10069664 Term: Atopic keratoconjunctivitis System Organ Class: 10015919 - Eye disorders MedDRA version: 21.0 Level: PT Classification code 10081000 Term: Vernal keratoconjunctivitis System Organ Class: 10015919 - Eye disorders MedDRA version: 21.0 Level: LLT Classification code 10081002 Te
Conditions
Interventions
Product Name: rVA576
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Not available
Current Sponsor code: rVA576
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
Akari Therapeutics Plc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints will include: • 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 • Visual acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) charts comparison from Day 1 to Day 56 • Change from Day 1 in composite clinical scores at Day 14, 28, 42 and 56 • Number and percentage of patients with MMP-9 positive levels at Days 1, 28 and 56 • 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 | — |
Countries
Spain
Contacts
Public ContactDavy Yeung
Tailored Clinical Research Solutions
Outcome results
None listed