Trial studying safety and effects for Hidradenitis Suppurativa (HS)
Official title Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07828860
What this study is testing
What is Soquelitinib?
Soquelitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa (hs).
Also referred to as CPI-818.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF)
- A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.
- A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory...
- Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.
- HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage...
You likely can't join if
- Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive...
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1)...
- Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection...
- History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (eg, unstable angina, unstable arterial hypertension...
See the full eligibility criteria
- Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF)
- A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.
- A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits.
- Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.
- HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline (Day 1) visits.
- History of inadequate response, intolerance, or contraindication to a course of systemic antibiotics for treatment of HS or exhibited recurrence after discontinuation of antibiotics through study participant interview...
- Willing and able to undergo the required skin biopsies. Key
- Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study...
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions.
- Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of...
- History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (eg, unstable angina, unstable arterial hypertension, moderate to severe heart failure [New York Heart Association Class...
The study team makes the final eligibility decision.
Where it's taking place
- West Lafayette, Indiana, United States
- Bowling Green, Kentucky, United States
- Owensboro, Kentucky, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- The Bronx, New York, United States
- Fargo, North Dakota, United States
- Mayfield Heights, Ohio, United States
- Camp Hill, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Lafayette, Indiana, United States; Bowling Green, Kentucky, United States; Owensboro, Kentucky, United States; Boston, Massachusetts, United States; New York, New York, United States; The Bronx, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.