AVTX-009 for Hidradenitis Suppurativa

(LOTUS Trial)

Not currently recruiting at 106 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AVTX-009 to determine its effectiveness for individuals with moderate to severe Hidradenitis Suppurativa (HS), a painful skin condition characterized by inflamed lumps and sores. Researchers aim to assess whether AVTX-009 is safe and more effective than a placebo (a non-active substance). Participants will receive either one of two AVTX-009 regimens or a placebo. Candidates may qualify for this trial if they have experienced HS symptoms for at least six months and have at least five inflamed spots in two different areas of the body. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AVTX-009 is being tested for safety in treating hidradenitis suppurativa (HS), a condition that causes painful lumps under the skin. Since AVTX-009 is in a Phase 2 trial, it has already undergone initial safety testing. Earlier studies have found it to be generally safe for humans, but more information is needed for confirmation.

Participants in earlier trials have tolerated AVTX-009 well, with no major safety issues reported so far. However, as with any treatment still under study, side effects that haven't been fully identified may exist. Prospective participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Researchers are excited about AVTX-009 for hidradenitis suppurativa because it offers a potentially new approach to managing this chronic skin condition. While most current treatments, like antibiotics and biologics, focus on reducing inflammation or infection, AVTX-009 may work by targeting specific pathways involved in the disease process. This could mean more precise treatment with possibly fewer side effects. Additionally, the two different regimens of AVTX-009 provide flexibility in dosing, which might lead to better tailored treatments for patients.

What evidence suggests that AVTX-009 might be an effective treatment for Hidradenitis Suppurativa?

Research is exploring AVTX-009 as a treatment for moderate to severe hidradenitis suppurativa (HS), a painful skin condition. Participants in this trial will receive either AVTX-009 regimen 1, AVTX-009 regimen 2, or a placebo. The main goal is to determine if AVTX-009 can help more patients significantly reduce their symptoms, aiming for a 75% improvement, known as HiSCR75. This treatment is compared to a placebo to assess its effectiveness. While detailed results are not yet available, the focus on achieving HiSCR75 suggests researchers are hopeful about its potential benefits. If successful, AVTX-009 could offer a new option for those dealing with HS. ^{1 3 5 6 7}

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+

Citations

1. ir.avalotx.com ir.avalotx.com/news-events-presentations/press-releases/detail/211/avalo-therapeutics-announces-completion-of-enrollment-in-phase-2-lotus-trial-of-avtx-009-for-the-treatment-of-hidradenitis-suppurativa

Avalo Therapeutics Announces Completion of Enrollment ... Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We're also exploring additional opportunities to ...

2. dermatologytimes.com dermatologytimes.com/view/avtx-009-completes-enrollment-in-hs-phase-2-trial

AVTX-009 Completes Enrollment in HS Phase 2 Trial The trial's primary endpoint is the proportion of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16.

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-of-avtx-009-for-treating-moderate-to-severe-hidradenitis-suppurativa-in-patients/

Study on the Effectiveness of AVTX-009 for Treating ... This clinical trial investigates the safety and efficacy of AVTX-009, an injectable treatment developed by Avalo Therapeutics, for patients with moderate to ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/533195

A Study to Evaluate the Efficacy and Safety of AVTX-009 in ... 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 ...

5. thedermdigest.com thedermdigest.com/hs-pipeline-watch-first-patient-dosed-in-phase-2-trial-of-avtx-009-topline-data-expected-in-2026/

HS Pipeline Watch: First Patient Dosed in Phase 2 Trial of ... ... AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa.

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-avtx-009-in-patients-with-moderate-to-severe-hidraden

A Study to Evaluate the Efficacy and Safety of AVTX-009 in ... 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 ...

7. uclahealth.org uclahealth.org/clinical-trials/study-evaluate-efficacy-and-safety-avtx-009-patients-with

A Study to Evaluate the Efficacy and Safety of AVTX-009 in ... 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 ...