Overview

Topical rVA576 for Treatment of Atopic Keratoconjunctivitis

Status:
Terminated

Trial end date:
2020-12-15

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AKARI Therapeutics

Criteria

Inclusion Criteria:

1. Aged 18 and above

2. Diagnosis of moderate to severe AKC with a composite symptom/sign score from one eye
of ≥ 22 out of 33 (see Clinical Scoring 17.1)

3. Will have had maximal topical therapy for at least 3 months without improvement but
will not currently be receiving systemic immunotherapy.

4. History of atopy other than ocular (dermatitis, asthma, hay fever)

5. Willing to give informed consent

6. Willing to use adequate contraceptive precautions for the duration of the study and
for 90 days thereafter

7. Willing to avoid prohibited medications for the duration of the study

Exclusion Criteria:

1. Eye surface disease other than AKC

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. Glaucoma

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. Failure to satisfy the PI of suitability to participate for any other reason