Lotus Trial

LOTUS at a glance

Who can participate:

Adults with HS

Duration of participation:

Up to 24 weeks (about 6 months)

Number of visits:

12 total (about 1 visit every 2 weeks)

Number of participants:

About 222 people

Locations:

Taking place globally

LOTUS is a Phase 2 trial looking at a potential new medicine called AVTX-009 to see if it can help people with HS

You may be able to join if you:

Are 18 or older

Have had symptoms of HS for 6 months or more

Even if you have taken another biologic therapy for HS, you may still be eligible

There are other criteria that must be met.

What does participation look like?

If you participate, you will be part of the trial for about 6 months:

Screening period

Screening is done to answer your questions and to see if you are eligible for LOTUS.

Treatment period

This is when you will receive the trial medication (AVTX-009) or placebo (see details below).

Follow-up period

You will no longer be receiving trial medication but will still be monitored for a short period of time.

Trial treatments

If you are eligible and decide to participate, a computer will randomly assign you to one of the following groups:

Higher dose AVTX-009 alternating with placebo every 2 weeks

Lower dose AVTX-009 every 2 weeks

Placebo every 2 weeks

A placebo is an inactive substance that looks like the trial drug (AVTX-009) but does not have any effect on the condition being studied (in this case, HS).

All treatments (AVTX-009 or placebo) are given as an injection just under the skin every 2 weeks for 14 weeks. Injections are given at the trial center by trained medical professionals.

There is a 2-in-3 chance of receiving AVTX-009. You cannot choose which treatment group you will be in, and neither you or your trial doctor will know which group you are in (though you can find out in an emergency).

Trial tests

During clinic visits, trial staff may:

Ask about medical history, HS and current and previous medications

Draw blood

Conduct a physical exam, including height, weight, blood pressure, heart rate and body temperature measurements

Perform an ECG, which measures the electrical activity of your heart

Examine your skin to assess the severity of HS

Perform a chest scan to check for infection

Ask you to fill out questionnaire(s) to see how HS is affecting your life

You will also be given training on how to complete an electronic diary

About AVTX-009

The investigational medicine being looked at in LOTUS is called AVTX-009. It’s thought to work by blocking an important driver of inflammation called IL-1β.^1-3 Blocking IL-1β can potentially reduce or even stop the inflammation that underlies HS.^1,4,5

Blocking IL-1β has been shown to be effective in other diseases involving inflammation. However, to date, AVTX-009 has not been studied in people with HS.

About hidradenitis suppurativa (HS)

HS is a chronic inflammatory skin condition.^6-9 Inflammatory means the body’s immune system is attacking healthy tissue by mistake. People with HS can have painful abscesses, nodules and/or scarring that progresses over time.^6-9 HS often appears in the armpits, groin and under the breasts.¹⁰ It usually starts in young adulthood and 1%–4% of people are affected.^11-13 HS is more common in women, people who smoke or are overweight and people who have relatives with HS.^{11, 12, 14-17} Symptoms can range from mild to severe and can have a large impact on quality of life.¹⁸

HS can be hard to diagnose and treat. People wait on average 7–10 years to get a correct diagnosis.¹⁰ There are also limited treatment options. Antibiotics, biologic medicines and sometimes surgery are used, but these only address symptoms, not the underlying cause of the disease. Thus, there is an urgent need for new medicines that target HS. This is why trials like LOTUS are being done.

Clinical trials FAQ

What are clinical trials?

Clinical trials, also called clinical studies or research trials, look at how well a investigational medicine works and if there are side effects. The US FDA and other regulatory agencies require these trials to make sure that medicines are tested correctly.

There are 4 phases of clinical trials. LOTUS is a Phase 2 trial, meaning AVTX-009 (or placebo) is given to people with the condition it’s intended to treat (in this case, HS). In Phase 2 trials, researchers are looking for the best dose for the medicine, as well as to see if it is safe and it works.

What is informed consent?

Before people can be part of a clinical trial, they are told about the trial and sign a document called informed consent. Informed consent helps make sure people understand what participation will be like and the potential risks and benefits of taking part in the trial.

What does participation involve?

Clinical trials differ, but participation often involves visits to a clinic and taking the investigational medicine (or placebo) over a period of time. With LOTUS, about 12 visits over 6 months are required. At these visits, AVTX-009 (or placebo) is given, questions are asked and answered and medical tests are performed.

What is a placebo?

A placebo is commonly used in clinical trials. It looks just like the potential medicine being tested but does not have the ingredients that make up that medicine. People are usually given the investigational medicine or placebo in a “blind” manner, meaning people don’t know what they are getting. (It’s possible to find out in an emergency.)

What are the benefits and risks?

People who join clinical trials are helping others with their condition, as the trials help to find better treatments for disease. Clinical trials can also potentially provide access to investigational medicines that are not otherwise available. In terms of risks, side effects are a possibility, and people may not receive the investigational medicine. Even if they do receive it, it may not work.

What happens if a person changes their mind about being part of a clinical trial?

Being part of a clinical trial is always 100% voluntary. People can change their minds about participating at any time.

Is compensation offered?

Many clinical trials, including LOTUS, may offer some compensation for your time and effort as well as transportation costs and other costs related to trial participation. It doesn’t cost anything to participate, and participants will not be charged for any procedure performed specifically as part of the trial.

How do I know if I qualify?

Clinical trials have criteria that people must meet to join. The trial staff asks questions and does tests to see if a person is eligible.

Where can I get more information?

For more about clinical trials in general, visit clinicaltrials.gov.

For more about LOTUS, contact the trial staff at avaloclinicaltrials@avalotx.com or 410-522-8707.

Resources

More information about clinical trials > Information about LOTUS on clinicaltrials.gov > Information about Avalo, the company behind the LOTUS trial >

For more information about HS and access to resources for people with HS, visit these sites:

Hidradenitis Suppurativa Foundation (HSF) > HS Connect > Hope for HS > DermNet > MedlinePlus >

References: 1. Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2. Bihorel S et al. AAPS J. 2014;16(5):1009-1017. 3. Data on file. 4. Kany S et al. Int J Mol Sci. 2019;20(23):6008. 5. Kimball AB et al. Late-breaking abstract. In: American Academy of Dermatology Annual Meeting, 8-12 March 2024, San Diego, CA. 6. Diaz MJ et al. Curr Iss Mol Bio. 2023;45(5):4400-4415. 7. Agnese ER et al. Cureus. 2023;15(11):e49390. 8. de Oliveira ASLE et al. Biomolecules. 2022;12(10):1371. 9. Sabat R et al. Lancet. 2025;405(10476):420-438. 10. Ingram JR et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-1605. 11. Garg A et al. JAMA Dermatol. 2017;153(8):760-764. 12. Ingram JR. Br J Dermatol. 2020;183(6):990-998. 13. Nguyen TV et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61. 14. Krajewski PK et al. Int J Dermatol. 2024;63(6):799-805. 15. Rached NA et al. Ann Med. 2024;56(1):2382372. 16. Vinkel C, Thomsen SF. J Clin Aesthet Dermatol. 2018;11(10):17-23. 17. Wolk K et al. Br J Dermatol. 2020;183(6):999-1010. 18. Caccavale S et al. Life (Basel). 2023;13(1):189.