A Study of SL-325 in Participants With Hidradenitis Suppurativa
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderate to Severe Hidradenitis Suppurativa (RECEPTIVE-HS1)
The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with Hidradenitis Suppurativa.
The study consists of a screening period of up to 5 weeks, a 16-week primary treatment period, 36-week extension period, and a follow-up period of up to 12 weeks.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Shattuck Medical Director
- Telefonnummer: 919-864-2700
- E-mail: clinicaltrials@shattucklabs.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- A clinical diagnosis of HS at Screening as assessed by the Investigator.
- Signs and symptoms of HS for ≥6 months prior to Screening.
- ≥5 total AN count.
- HS lesions present in ≥2 distinct anatomical areas.
- ≥1 anatomic area of HS involvement characterized as Hurley Stage II or III.
- Draining tunnel count of ≤20.
- Inadequate response or recurrence of disease activity after an appropriate course of systemic antibiotics for the treatment of HS OR intolerance or contraindication to systemic antibiotics for the treatment of HS.
Exclusion Criteria:
- Evidence of other active skin disease or condition that could, in the Investigator's opinion, interfere with the evaluation of HS.
- Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component.
- Active tuberculosis (TB) or inadequately treated latent tuberculosis infection (LTBI)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo administered intravenously |
|
Eksperimentel: SL-325 high dose
|
SL-325 administered intravenously |
|
Eksperimentel: SL-325 low dose
|
SL-325 administered intravenously |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving HiSCR50
Tidsramme: Week 16
|
The proportion of participants achieving HiSCR50, defined as a ≥50% reduction in total AN count, with no increase in abscess count and no increase in draining tunnel count, relative to baseline. |
Week 16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving HiSCR75
Tidsramme: Week 16
|
The proportion of participants achieving HiSCR75, defined as a ≥75% reduction in the total AN count, with no increase in abscess count and no increase in draining tunnel count, relative to baseline. |
Week 16
|
|
Incidence and severity of treatment-emergent adverse events
Tidsramme: Week 16
|
Incidence and severity of treatment-emergent adverse events (TEAEs) |
Week 16
|
|
Number of participants who discontinue study intervention due to an TEAE
Tidsramme: Week 16
|
Treatment-emergent adverse events (TEAEs) leading to discontinuation of study intervention |
Week 16
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SL-325-202
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. Proposals will be reviewed based on scientific need, conflicts of interest, and regulatory approval status.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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