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New treatment option for Hidradenitis Suppurativa
Official title A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
ClinicalTrials.gov ID: NCT05889182
What this study is testing
What is Upadacitinib?
Upadacitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa.
Also referred to as ABT-494, RINVOQ.
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
- Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history...
- Documented history of previous use of \>= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF...
- Participant must have a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline.
- HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
You likely can't join if
- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral)...
- Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the...
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or...
- Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
- Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline...
See the full eligibility criteria
- Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant).
- Documented history of previous use of \>= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate...
- Participant must have a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline.
- HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- Draining fistula count of \<= 20 at Baseline.
- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
- Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another...
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
- Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
- Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fountain Hills, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Fayetteville, Arkansas, United States
- Hot Springs, Arkansas, United States
- North Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Encino, California, United States
- Huntington Beach, California, United States
- Los Angeles, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Thousand Oaks, California, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Brandon, Florida, United States
+ 231 more site(s).
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fountain Hills, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Fayetteville, Arkansas, United States and 245 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.