ACTIVE_NOT_RECRUITING

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

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Conditions

Hidradenitis SuppurativaHSacne inversaAVTX-009LY2189102FL-101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-09-16
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06603077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
  2. 2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.
  1. 1. Has a draining fistula count of ≥ 20.
  2. 2. 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.
  3. 3. 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).
  4. 4. Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.

Contacts and Locations

Study Locations (Sites)

Clinical Site 1022
Scottsdale, Arizona, 85260
United States
Clinical Site 1037
Scottsdale, Arizona, 85260
United States
Clinical Site 1026
Tucson, Arizona, 85704
United States
Clinical Site 1032
Northridge, California, 91325
United States
Clinical Site 1019
Pomona, California, 91767
United States
Clinical Site 1009
Sacramento, California, 95815
United States
Clinical Site 1034
Santa Monica, California, 90024
United States
Clinical Site 1011
Washington D.C., District of Columbia, 20010
United States
Clinical Site 1029
Boca Raton, Florida, 33486
United States
Clinical Site 1002
Coral Gables, Florida, 33134
United States
Clinical Site 1015
Maitland, Florida, 32751
United States
Clinical Site 1027
North Miami Beach, Florida, 33162-4708
United States
Clinical Site 1013
Tampa, Florida, 33613
United States
Clinical Site 1008
Savannah, Georgia, 31419
United States
Clinical Site 1014
Chicago, Illinois, 60640
United States
Clinical Site 1028
West Lafayette, Indiana, 47906
United States
Clinical Site 1031
Bowling Green, Kentucky, 42104
United States
Clinical Site 1024
Murray, Kentucky, 42071
United States
Clinical Site 1042
Boston, Massachusetts, 02115-5804
United States
Clinical Site 1001
Boston, Massachusetts, 02215
United States
Clinical Site 1030
Detroit, Michigan, 48201
United States
Clinical Site 1007
Fort Gratiot, Michigan, 48059
United States
Clinical Site 1041
Oakland, Michigan, 48328
United States
Clinical Site 1003
Portsmouth, New Hampshire, 03801
United States
Clinical Site 1036
Brooklyn, New York, 10023
United States
Clinical Site 1016
New York, New York, 10003
United States
Clinical Site 1023
The Bronx, New York, 10467
United States
Clinical Site 1020
Cincinnati, Ohio, 45219
United States
Clinical Site 1010
Cleveland, Ohio, 44106
United States
Clinical Site 1017
Dublin, Ohio, 43016
United States
Clinical Site 1004
Philadelphia, Pennsylvania, 19103
United States
Clinical Site 1035
Pittsburgh, Pennsylvania, 15213
United States
Clinical Site 1018
Johnston, Rhode Island, 02919
United States
Clinical Site 1025
Providence, Rhode Island, 02903
United States
Clinical Site 1005
Greenville, South Carolina, 29615
United States
Clinical Site 1012
Arlington, Texas, 76011
United States

Collaborators and Investigators

Sponsor: Avalo Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Hidradenitis Suppurativa
  • HS
  • acne inversa
  • AVTX-009
  • LY2189102
  • FL-101

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa