TRACKER

• Research type

  Research Study

• Full title

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

• IRAS ID

  250542

• Contact name

  Sajjad Ahmad

• Contact email

  Sajjad.Ahmad@moorfields.nhs.uk

• Sponsor organisation

  Akari Therapeutics Plc

• Eudract number

  2017-002835-40

• Duration of Study in the UK

  0 years, 8 months, 30 days

• Research summary

  Research Summary:
  Atopic keratoconjunctivitis (AKC) is a long-term allergic condition of the eyelids and front surface of the eye. Treatment for AKC is initially topical (applied directly to a part of the body, in this case, the eye) and includes eye drops, antihistamines (a type of medicine often used to treat allergies), immunomodulators (medications used to help normalize the immune system like Ciclosporin A) and intermittent steroids (drugs that calm and prevent inflammation).
  
  However, systemic immunotherapy (a treatment that helps to boost the body's immune system) may become necessary in patients who don’t respond to topical therapy. This usually affects 10 - 15% of the population with 5 – 10% of patients who experience severe AKC progressing to complete vision loss.
  
  AKC affects mainly adults and symptoms usually include itching, burning, tearing, and swollen eye lids. There is currently a need for treatments that will prevent the progression of the disease.
  
  In this study, we are seeking to investigate the safety and tolerability (how well patients cope with the drug) of rVA576 in the treatment of AKC.
  
  When the first three patients have completed two weeks of treatment, the safety and tolerability will be reviewed by the lead doctor working on the study at the site (principal investigator) and an independent assesor. Provided that the data is favourable, part 2 of the study will begin.
  
  Part 2 of the study involves 16 patients. They will be randomised 1:1. This means that 8 patients will receive the active drug and 8 patients will receive the placebo. The researchers and the participants will not know which treatment is being administered.
  
  All randomised patients will be seen and assessed at every two weeks until the end of the active part of the study by a masked observer who will not know whether the patient is on active or placebo treatment. There will be one follow up visit after the end of active treatment.

  Summary of results:
  Introduction The Tracker Study was sponsored and funded by Akari Therapeutics Plc, and recruited patients from March 2019 to April 2020. The study investigated whether an unlicensed drug called nomacopan (also known as rVA576) could benefit people with atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC), and severe allergic conjunctivitis (SAC) – either seasonal or perennial.

  Where the study took place
  This study was conducted in the UK at the following hospitals:
  • Moorfields Eye Hospital
  • Bristol Eye Hospital,
  • Royal Liverpool University Hospital,
  • Royal Victoria Infirmary, Newcastle-Upon-Tyne, • St James's University Hospital, Leeds, • Southend University Hospital NHS Foundation Trust • Addenbrookes Hospital

  The study was also opened in 2 sites in Spain:
  • Hospital Clinic de Barcelona
  • Instituto Universitario de Oftalmobiología Aplicada

  Who participated in the study?
  In total, 12 patients were recruited to the study. 8 patients were diagnosed with AKC, 2 patients with VKC and 2 patients with seasonal SAC.

  What treatments did the participants receive?
  Patients received either nomacopan or placebo – the study drug. The study drug was given as eyes drops into both eyes, twice a day, for a maximum of 56 days.

  This study was two parts - Part 1 and Part 2.
  • In Part 1 - 3 patients were treated with nomacopan. The data collected was then reviewed by the Principal Investigator and an independent clinician. The review indicated it was safe to recruit patients to Part 2 of the study.
  • In Part 2 - 9 patients were treated with the study drug. Patients were randomised (assigned by chance, like the flip of a coin) to receive either nomacopan or placebo. Of the 9 patients treated, 6 received placebo and 3 received nomacopan.

  What were the results of the study?
  The study showed nomacopan is safe and, as expected, most adverse events that were reported related to the eye. Eye disorders that were reported include AKC, red eye, dry eye, eczema on the eyelid, discharge from the eye, itchy eyes, eye swelling and blurred version. There were no serious side effects. Unfortunately, the study was closed early due to the COVID-19 pandemic in 2020 and therefore, not enough patients were recruited to confirm if nomacopan was effective in treating AKC, VKC or SAC.

  Where can I learn more?
  The results of the study can be found on the clinicaltrials.gov website and searching the study number: NCT04037891 or following this link: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAM-2Fmn1KqsY-2FdsuT6DtllfkOA-3D-3Du6oA_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLx61Fg0SfdOQxdTVmUpiVz8X62ZQl6fpZkeU9jF6wwuuQlQJR3GAt8iIlbAuWa5Tp-2Fo-2FJPZE-2FcA33dsJD9tnERPaQf3UQU4N5NtD5uk7rtvqercCSPWg3MKYrWATBTZxbMfUrK81ZcH2liBFXy-2FnhWeCQIKbnp9jKy3jl38eonWQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C19b1c1a0e09042e5c62a08da326fe644%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637877753419814148%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=nLqAFnun7B1lZIGg73V2xTuNmoTxUXtrMRbgc0%2F0qnU%3D&reserved=0

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  18/NE/0264

• Date of REC Opinion

  27 Sep 2018

• REC opinion

  Further Information Favourable Opinion