Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Fountain Valley, California.

Sponsor
MoonLake Immunotherapeutics AG
Study ID
NCT05322473
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonelokimab (M1095) — DRUG
    randomized treatment; parallel-group
  • Adalimumab — DRUG
    randomized treatment; parallel-group
  • Placebo — OTHER
    randomized treatment; parallel-group

Study Details

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

Key Dates

First listed
Apr 11, 2022
Start date
Apr 25, 2022
Status verified
May 2024
Primary completion
May 9, 2023
Completion
Aug 30, 2023

Study Design

Enrollment
234 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: sonelokimab dose 1 (120 mg)
    Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
  • Experimental: sonelokimab dose 2 (240 mg)
    Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
  • Active Comparator: adalimumab
    Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12 [ Time Frame: At Week 12 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Clinical SiteFountain ValleyCalifornia92708-
Clinical SiteLos AngelesCalifornia90056-
Clinical SiteMiamiFlorida33136-
Clinical SiteOrmond BeachFlorida32127-
Clinical SiteSt. PetersburgFlorida33709-
Clinical SiteTampaFlorida33613-
Clinical SiteIndianapolisIndiana46250-
Clinical SiteBeverlyMassachusetts01915-
Clinical SiteBostonMassachusetts02215-
Clinical SiteOmahaNebraska68144-
Clinical SiteNew YorkNew York10003-
Clinical SitePhiladelphiaPennsylvania19103-
Clinical SiteCharlestonSouth Carolina29425-
Clinical SiteNashvilleTennessee37215-
Clinical SiteBellaireTexas77401-

Related coverage on Hipa.ai

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By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease

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