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Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
clinicaltrials@northshore.org
ALL
12 years to 17 years old
PHASE2
NCT07213973
Inclusion Criteria:
* Aged ≥ 12 to \< 18 years at the time of informed consent/assent signing.
* Body weight ≥ 30 kg at both screening and baseline visits.
* Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
* Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
* HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
* Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
* Agreement to use contraception.
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.
Exclusion Criteria:
* Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply. DRUG: Povorcitinib
Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
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 (Step-Up HS)
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
NCT05889182
Inclusion 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 response or for any duration characterized by intolerance as determined by the investigator.
* 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.
Exclusion Criteria:
* 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 interventional clinical study. Investigational drugs are also prohibited during the study.
* 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. DRUG: Upadacitinib, DRUG: Placebo
Hidradenitis Suppurativa
Hidradenitis Suppurativa, Upadacitinib, ABT-494, Rinvoq, STEP-UP HS
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT06046729
Inclusion Criteria:
* Have a diagnosis of HS for at least 12 months.
* Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
* Have an (abscess plus inflammatory nodule) count of at least 5.
* Agree to use topical antiseptics daily.
* Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Exclusion Criteria:
* Have more than 20 draining fistulae.
* Have had surgical treatment for HS in the last 4 weeks before randomization.
* Have an active skin disease or condition, that could interfere with the assessment of HS.
* Have a current or recent acute, active infection.
* Are immunocompromised.
* Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening. DRUG: Eltrekibart, DRUG: Placebo
Hidradenitis Suppurativa
A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT07228390
Key Eligibility Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
Inclusion Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
Exclusion Criteria:
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
DRUG: Ritlecitinib, DRUG: Placebo
Hidradenitis Suppurativa
Ritlecitinib