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Hidradenitis SuppurativaPhase 2LOTUSNCT06603077

A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

A Phase 2 study testing AVTX-009 Regimen 1 and AVTX-009 Regimen 2 in people with Hidradenitis Suppurativa, run by Avalo Therapeutics, Inc. at 89 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
AVTX-009 Regimen 1 and AVTX-009 Regimen 2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
253 participants
Where
89 sitesin 13 countries
Study dates
16 Sep 2024to 17 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
  • At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.

Who cannot join

  • Has a draining fistula count of ≥ 20.
  • Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS.
  • History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS).
  • Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.

Trial locations and contacts

89 sites in 13 countries.

89 sites in 13 countries

United States36 sites

  • Clinical Site 1012

    Arlington, Texas, 76011

  • Clinical Site 1029

    Boca Raton, Florida, 33486

  • Clinical Site 1042

    Boston, Massachusetts, 02115-5804

  • Clinical Site 1001

    Boston, Massachusetts, 02215

  • Clinical Site 1031

    Bowling Green, Kentucky, 42104

  • Clinical Site 1036

    Brooklyn, New York, 10023

  • Clinical Site 1014

    Chicago, Illinois, 60640

  • Clinical Site 1020

    Cincinnati, Ohio, 45219

  • Clinical Site 1010

    Cleveland, Ohio, 44106

  • Clinical Site 1002

    Coral Gables, Florida, 33134

  • Clinical Site 1030

    Detroit, Michigan, 48201

  • Clinical Site 1017

    Dublin, Ohio, 43016

  • Clinical Site 1007

    Fort Gratiot, Michigan, 48059

  • Clinical Site 1005

    Greenville, South Carolina, 29615

  • Clinical Site 1018

    Johnston, Rhode Island, 02919

  • Clinical Site 1015

    Maitland, Florida, 32751

  • Clinical Site 1024

    Murray, Kentucky, 42071

  • Clinical Site 1016

    New York, New York, 10003

  • Clinical Site 1027

    North Miami Beach, Florida, 33162-4708

  • Clinical Site 1032

    Northridge, California, 91325

  • Clinical Site 1041

    Oakland, Michigan, 48328

  • Clinical Site 1004

    Philadelphia, Pennsylvania, 19103

  • Clinical Site 1035

    Pittsburgh, Pennsylvania, 15213

  • Clinical Site 1019

    Pomona, California, 91767

  • Clinical Site 1003

    Portsmouth, New Hampshire, 03801

  • Clinical Site 1025

    Providence, Rhode Island, 02903

  • Clinical Site 1009

    Sacramento, California, 95815

  • Clinical Site 1034

    Santa Monica, California, 90024

  • Clinical Site 1008

    Savannah, Georgia, 31419

  • Clinical Site 1022

    Scottsdale, Arizona, 85260

  • Clinical Site 1037

    Scottsdale, Arizona, 85260

  • Clinical Site 1013

    Tampa, Florida, 33613

  • Clinical Site 1023

    The Bronx, New York, 10467

  • Clinical Site 1026

    Tucson, Arizona, 85704

  • Clinical Site 1011

    Washington D.C., District of Columbia, 20010

  • Clinical Site 1028

    West Lafayette, Indiana, 47906

Other trials in United States

Canada9 sites

  • Clinical Site 1103

    Barrie, Ontario, L4M 7G1

  • Clinical Site 1105

    Edmonton, Alberta, T5K 1X3

  • Clinical Site 1108

    Edmonton, Alberta, T6W 4V4

  • Clinical Site 1104

    Hamilton, Ontario, L8L 3C3

  • Clinical Site 1107

    London, Ontario, N6A 2C2

  • Clinical Site 1110

    Montreal, Quebec, H1Y 3L1

  • Clinical Site 1111

    Québec, G1W 4R4

  • Clinical Site 1101

    Saskatoon, Saskatchewan, S7K 2C1

  • Clinical Site 1106

    Toronto, Ontario, M2N 3A6

Other trials in Canada

Italy7 sites

  • Clinical Site 1902

    Ferrara, 44124

  • Clinical Site 1908

    Milan, 20122

  • Clinical Site 1906

    Pisa, 56126

  • Clinical Site 1907

    Roma, 00144

  • Clinical Site 1904

    Roma, 168

  • Clinical Site 1903

    Rozzano, Milano, 20089

  • Clinical Site 1901

    Torrette, Ancona, 60126

Other trials in Italy

Poland6 sites

  • Clinical Site 1703

    Bialystok, Podlaskie Voivodeship, 15-453

  • Clinical Site 1704

    Ossy, Silesian Voivodeship, 42-624

  • Clinical Site 1701

    Warszawa, Pomeranian Voivodeship, 02-507

  • Clinical Site 1705

    Warszawa, Pomeranian Voivodeship, 02-962

  • Clinical Site 1702

    Wroclaw, Kuyavian-Pomeranian Voivodeship, 51-685

  • Clinical Site 1706

    Wroclaw, Lower Silesian Voivodeship, 50-566

Other trials in Poland

France5 sites

  • Clinical Site 1505

    Amiens, Picardie, 80054

  • Clinical Site 1503

    Antony, Hauts-de-Seine, 92160

  • Clinical Site 1502

    Lyon, Rhône, 69003

  • Clinical Site 1504

    Paris, Île-de-France Region, 75010

  • Clinical Site 1501

    Rouen, Seine-Maritime, 76031

Other trials in France

Germany5 sites

  • Clinical Site 1601

    Bochum, North Rhine-Westphalia, 44791

  • Clinical Site 1605

    Dresden, Saxony, 01307

  • Clinical Site 1606

    Erlangen, Bavaria, 91054

  • Clinical Site 1604

    Frankfurt am Main, Hesse, 60590

  • Clinical Site 1602

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Australia4 sites

  • Clinical Site 1202

    Carlton, Victoria, 3053

  • Clinical Site 1203

    Darlinghurst, New South Wales, 2010

  • Clinical Site 1201

    Westmead, New South Wales, 2145

  • Clinical Site 1204

    Woolloongabba, Queensland, 4102

Other trials in Australia

Bulgaria4 sites

  • Clinical Site 1302

    Lovech, 5500

  • Clinical Site 1301

    Pleven, 5800

  • Clinical Site 1303

    Sofia, Sofia-Grad, 1463

  • Clinical Site 1304

    Stara Zagora, 6003

Other trials in Bulgaria

Spain4 sites

  • Clinical Site 1802

    Granada, 18012

  • Clinical Site 1803

    Madrid, 28034

  • Clinical Site 1801

    Manises, Valencia, 46940

  • Clinical Site 1804

    Seville, 41009

Other trials in Spain

Greece3 sites

  • Clinical Site 2103

    Athens, Attica, 124 62

  • Clinical Site 2101

    Athens, Attica, 16121

  • Clinical Site 2102

    Efkarpia, Thessaloniki, 56429

Other trials in Greece

Czechia2 sites

  • Clinical Site 1401

    Prague, Prague, 100 34

  • Clinical Site 1402

    Prague, Prague, 150 06

Other trials in Czechia

Slovakia2 sites

  • Clinical Site 2202

    Svidník, Presov, 089 01

  • Clinical Site 2201

    Trnava, Trnava Region, 917 75

Other trials in Slovakia

Turkey (Türkiye)2 sites

  • Clinical Site 2001

    Gaziantep, 27310

  • Clinical Site 2002

    Samsun, 55270

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)

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).

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio.

The study will comprise:

  1. A Screening Period which will last up to 28 days.
  2. A Treatment Period up to 16 weeks.
  3. A Follow-up period of 6 weeks after the last dose of study drug.

The maximum clinical trial duration for each participant is 24 weeks.

Being tested
AVTX-009 Regimen 1, AVTX-009 Regimen 2, Placebo
Keywords
Hidradenitis Suppurativa, HS, acne inversa, AVTX-009, LY2189102, FL-101
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVTX-009 Regimen 1Drug

    AVTX-009 will be administered as a subcutaneous injection every 4 weeks.

  • AVTX-009 Regimen 2Drug

    AVTX-009 will be administered as a subcutaneous injection every 2 weeks.

  • PlaceboDrug

    Matching placebo will be administered as a subcutaneous injection every 2 weeks.

Study groups in NCT06603077
Study groupRoleWhat they receive
AVTX-009 Regimen 1ExperimentalPatients will receive AVTX-009 regimen 1.
Receives: Drug: AVTX-009 Regimen 1
AVTX-009 Regimen 2ExperimentalPatients will receive AVTX-009 regimen 2.
Receives: Drug: AVTX-009 Regimen 2
PlaceboPlacebo comparatorPatients will receive matching placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

    HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.

    Measured: At Week 16

Secondary outcomes (9)

  1. Proportion of patients achieving HiSCR50

    HiSCR50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.

    Measured: At Week 16

  2. Proportion of patients achieving HiSCR90

    HiSCR90 is defined as at least a 90% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.

    Measured: At Week 16

  3. Change from Baseline in International HS Severity Score System (IHS4)

    IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease.

    Measured: Baseline (Day 1) and Week 16

  4. Change from Baseline in total abscess and inflammatory nodule (AN) count

    An abscess is a circumscribed collection of purulent exudates frequently associated with swelling, erythema, and other signs of inflammation, such as fluctuance, tenderness, and pain. An inflammatory nodule is a raised, deep-seated, three-dimensional, round nodule, greater than 10 mm in diameter. It is tender and erythematous without evidence of fluctuance.

    Measured: Baseline (Day 1) and Week 16

  5. Change from Baseline in draining fistula count

    Draining fistula is defined as a pathologic passageway connecting to the skin surface from dermis or subcutaneous tissue that drains serous or purulent fluid, either spontaneously or by gentle palpation.

    Measured: Baseline (Day 1) and Week 16

  6. Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from Baseline on a Numerical Rating Scale (NRS) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 (NRS30)

    The skin pain NRS is a single-item measure to capture the patient's self-reported skin pain severity by rating the worst level of skin pain in the last 24 hours as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Baseline (Day 1) and Week 16

  7. Percentage of patients with flares

    The number of patients with flares will be programmatically calculated based on the assessed lesion counts. A flare is defined as ≥ 25% increase in AN count plus an increase of ≥ 2 in AN count compared to Baseline.

    Measured: From Baseline (Day 1) to Week 16

  8. AVTX-009 anti-drug antibodies (ADA)

    The incidence of patients with AVTX-009 anti-drug antibodies (ADA).

    Measured: From Baseline (Day 1) to Week 20

  9. Safety and tolerability of AVTX-009

    Incidence of adverse events (AEs).

    Measured: From Baseline (Day 1) to Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start16 Sep 2024
  3. Primary completion23 Feb 2026
  4. Study completion17 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603077
Sponsor's protocol ID
AVTX-009-HS-201
Acronym
LOTUS
Status last verified
Apr 2026
First submitted
17 Sep 2024
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AVTX-009 Regimen 1 and AVTX-009 Regimen 2 in people with Hidradenitis Suppurativa, run by Avalo Therapeutics, Inc. at 89 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Canada, Italy, Poland, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06603077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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