AK006 IV for Hives

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Allakos Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.

Research Team

Chin Lee, MD, MPH

Principal Investigator

Allakos Inc.

Eligibility Criteria

This trial is for people who have chronic spontaneous urticaria (hives) that doesn't get better with antihistamines and have completed the main part of study AK006-001. Participants will receive additional treatment.

Inclusion Criteria

Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit

Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator

Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator

See 1 more

Exclusion Criteria

Pregnant, breastfeeding, or planning to become pregnant while participating in the study

I plan to use only approved or trial drugs for CSU, besides low-dose H1-AH.

Treatment Details

Interventions

AK006 (Monoclonal Antibodies)

Trial OverviewThe trial tests further doses of a drug called AK006 given through an IV every four weeks, up to four times. After treatments, there's a 16-week period where patients are checked for how well they tolerate the drug and its effectiveness.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 720mg of AK006 IVExperimental Treatment1 Intervention

Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks.