CompletedPhase 1

A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis

United States30 participantsStarted 2018-02-26

Plain-language summary

This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly intravenous infusion for 6 doses at up to 3 mg/kg.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provided written informed consent
✓. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form
✓. Confirmed diagnosis of AKC, VKC, or PAC and an average total ACS score of ≥15 calculated from all daily ACS questionnaires completed during the screening period (minimum of 14 daily ACS questionnaires must be completed). Total ACS score is the sum of itching, light sensitivity, eye pain, foreign body sensation, and watering symptom scores (and excludes atopic dermatitis, allergic asthma, and allergic rhinitis scores).
✓. History of topical corticosteroid and/or systemic corticosteroid use for the treatment of allergic conjunctivitis (AKC, VKC, or PAC)
✓. Stable dose(s) of allowed AKC, VKC, or PAC medication(s) during the 14 days prior to Day 1; and commitment to remaining on the same dose(s) of AKC, VKC, or PAC medication(s) for the entire duration of study participation (unless dose modification is due to unforeseen medical necessity) per Section 8.1 and Section 8.2.
✓. Willing and able to comply with the study procedures and visit schedule, including follow-up visits
✓. Negative Screening ova and parasite test
✓. Female patients must be either post-menopausal for at least 1 year with FSH level \>40 mIU/mL at Screening or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of child-bearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.

Exclusion criteria

What they're measuring

To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4.03

Timeframe: Adverse events will be collected starting from the time of first study drug infusion and ending at Day 309 (±7 Days) or the ET Visit unless directed otherwise by Allakos

Trial details

NCT IDNCT03379311

SponsorAllakos Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-08

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