AK006 IV for Hives

No longer recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AK006 for individuals with Chronic Spontaneous Urticaria, a condition causing itchy hives without a clear cause. Participants will receive the treatment through an IV (intravenous) infusion every four weeks to assess its safety and effectiveness. It is best suited for those who have already participated in a previous study with AK006 and completed all required visits. The trial aims to learn more about the treatment's effects over time. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AK006 is likely to be safe for humans?

Research shows that AK006 is generally safe for people. Studies found no serious problems in those who took AK006. Participants who received both single and multiple doses, including doses up to 720 mg, tolerated it well. The safety record appears positive so far. These findings suggest that AK006 is safe for humans, but further research is ongoing to learn more. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hives, which often include antihistamines and corticosteroids, AK006 is administered through an intravenous infusion, allowing for potentially faster and more direct delivery into the bloodstream. Researchers are excited about AK006 because it might offer a new mechanism of action, targeting immune pathways involved in chronic hives that current therapies don't address. This could mean more effective relief for patients who don't respond well to existing medications.

What evidence suggests that AK006 might be an effective treatment for hives?

Research shows that AK006 might help treat chronic spontaneous urticaria, also known as hives. Earlier studies found AK006 very effective in targeting mast cells, which play a key role in causing hives. In this trial, participants will receive 720 mg of AK006 via intravenous infusion. Previous studies showed that the highest dose of 720 mg achieved 98% receptor occupancy by day 113, indicating strong and lasting effects. This suggests AK006 could potentially reduce the frequency and severity of hives episodes by keeping the involved cells inactive for longer. Early findings indicate this treatment could provide relief for those dealing with chronic hives. ^{1 6 7 8 9}

Who Is on the Research Team?

Chin Lee, MD, MPH

Principal Investigator

Allakos Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. biospace.com biospace.com/press-releases/allakos-announces-topline-results-from-its-phase-1-trial-of-ak006-in-patients-with-chronic-spontaneous-urticaria-and-announces-restructuring

Allakos Announces Topline Results from its Phase 1 Trial ... Allakos Announces Topline Results from its Phase 1 Trial of AK006 in Patients with Chronic Spontaneous Urticaria and Announces Restructuring.

2. firstwordpharma.com firstwordpharma.com/story/5903028

Allakos Announces Phase 1 Trial Results of Subcutaneous ... Subcutaneously administered AK006 showed approximately 77% bioavailability and prolonged receptor occupancy on mast cells –

3. synapse.patsnap.com synapse.patsnap.com/article/allakos-shares-phase-1-results-for-subcutaneous-ak006-in-healthy-volunteers

Allakos Shares Phase 1 Results for Subcutaneous AK006 ... Particularly, the highest dose of 720 mg showed a receptor occupancy rate of 98% at day 113, pointing to the potential for less frequent dosing.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946961/

Update on the Treatment of Chronic Spontaneous Urticaria It confirmed the results of CUPID A with 30% of dupilumab-treated patients having complete response at 24 weeks compared with 18% of those on ...

5. ctv.veeva.com ctv.veeva.com/study/study-to-assess-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-ak006-in-healthy-su

Study to Assess the Safety, Tolerability, Pharmacokinetics and ... Description: Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.

6. sec.gov sec.gov/Archives/edgar/data/1564824/000095017025008992/allk-ex99_1.htm

EX-99.1 Safety Results. AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events (SAEs) in subjects on AK006.

7. biospace.com biospace.com/drug-development/allakos-announces-phase-1-trial-results-of-subcutaneous-ak006-in-healthy-volunteers

Allakos Announces Phase 1 Trial Results of Subcutaneous ... Single and multiple doses of IV AK006 and single dose subcutaneous AK006 up to 720 mg were well-tolerated with a favorable safety profile. In ...

8. withpower.com withpower.com/trial/phase-1-urticaria-7-2024-abde7

AK006 IV for Hives · Info for Participants This Phase 1 medical study run by Allakos Inc. needs participants to evaluate whether AK006 will have tolerable side effects & efficacy for patients with ...

9. synapse.patsnap.com synapse.patsnap.com/article/allakos-reports-positive-phase-1-ak006-trial-results-in-healthy-volunteers

Allakos Reports Positive Phase 1 AK006 Trial Results in ... The study found that AK006 displayed dose-linear exposure and has an estimated half-life of about 21 days at the 720 mg IV dose. The serum ...