Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Part of paid clinical trials in Rancho Mirage, California.

Sponsor
MoonLake Immunotherapeutics AG
Study ID
NCT05640245
Phase
PHASE2
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

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

Interventions

  • Sonelokimab — DRUG
    randomized treatment; parallel group
  • Placebo — DRUG
    randomized treatment; parallel-group
  • Adalimumab — DRUG
    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 active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.

Key Dates

First listed
Dec 7, 2022
Start date
Dec 13, 2022
Status verified
Aug 2026
Primary completion
Sep 5, 2023
Completion
Jan 15, 2024

Study Design

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

Arms

  • Experimental: sonelokimab dose regimen 1
    Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1
  • Experimental: sonelokimab dose regimen 2
    Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2
  • Experimental: sonelokimab dose regimen 3
    Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo
  • Active Comparator: adalimumab
    Subjects randomized to this arm will receive adalimumab

Primary Outcome Measure

Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 [ Time Frame: At Week 12 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Clinical SiteRancho MirageCalifornia92260-
Clinical SiteDuncansvillePennsylvania16635-

Related coverage on Hipa.ai

Related Studies