AVTX-009 for Hidradenitis Suppurativa

(LOTUS Trial)

Recruiting at 77 trial locations

Overseen By Mittie Doyle, MD, FACR

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Avalo Therapeutics, Inc.

Disqualifiers: Active skin condition, Chronic infection, Uncontrolled disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications for other active inflammatory conditions, you might need to stop them as they could interfere with the study.

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe Hidradenitis Suppurativa (HS). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I have at least 5 inflamed areas on my body, with one being moderate to severe.

I have had symptoms of HS for at least 6 months.

Exclusion Criteria

Has a draining fistula count of ≥ 20

I do not have any skin conditions or infections that need treatment which could affect my HS assessment.

I do not have chronic infections like kidney, lung infections, or open wounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 to 4 weeks

Treatment

Participants receive AVTX-009 or placebo for up to 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AVTX-009

Trial Overview The study tests the effectiveness and safety of AVTX-009 in two different regimens against a placebo. Participants will be randomly assigned to receive either one of the AVTX-009 regimens or a placebo.

How Is the Trial Designed?

Group I: AVTX-009 Regimen 2 Experimental Treatment 1 Intervention

Patients will receive AVTX-009 regimen 2.

Group II: AVTX-009 Regimen 1 Experimental Treatment 1 Intervention

Patients will receive AVTX-009 regimen 1.

Group III: Placebo Placebo Group 1 Intervention

Patients will receive matching placebo.

AVTX-009 is already approved in United States, United Kingdom, China, Japan for the following indications:

Approved in United States as AVTX-009 for:

• Hidradenitis Suppurativa (under investigation)

Approved in United Kingdom as AVTX-009 for:

• Hidradenitis Suppurativa (under investigation)

Approved in China as AVTX-009 for:

• Hidradenitis Suppurativa (under investigation)

Approved in Japan as AVTX-009 for:

• Hidradenitis Suppurativa (under investigation)

Who Is Running the Clinical Trial?

Avalo Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

2,100+