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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 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
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE3
NCT07665437
Key
Inclusion Criteria:
* Signed informed consent must be obtained before any assessment is performed.
* Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
* Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Key Exclusion Criteria:
* Ongoing or planned use of prohibited HS or non-HS treatments.
* Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
* Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Other protocol-defined inclusion/exclusion criteria may apply. DRUG: Remibrutinib
Hidradenitis Suppurativa
BTK inhibitor, hidradenitis suppurativa, HiSCR, remibrutinib, Phase 3, extension study
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (CLAROS)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT07225569
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
* Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
* Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
* History of recurrent or recent serious infection
* Known history of or suspected current immunosuppression
* History of solid organ transplant or stem cell transplant.
* History of splenectomy
* History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
* Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. DRUG: SAR445399, DRUG: Placebo
Hidradenitis Suppurativa