AK006 IV for Hives

Recruiting at 13 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Allakos Inc.

Must be taking: H1-AH

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

29 Participants Needed

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.

Will I have to stop taking my current medications?

The trial allows the use of a single 2nd- or later-generation H1-antihistamine (a type of allergy medication) at a specific dose, but other medications for hives may not be allowed. It's best to discuss your current medications with the trial team to see if they are permitted.

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety, tolerability, PK, immunogenicity, and clinical response after treatment

16 weeks

Open-label extension

Participants continue to receive the study drug in an open-label format

Treatment Details

Interventions

• AK006

Trial Overview The 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

Group I: 720mg of AK006 IV Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Allakos Inc.

Lead Sponsor

Trials

18

Recruited

1,600+