A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis

Part of paid clinical trials in Saint Joseph, Missouri.

Sponsor
Galderma R&D
Study ID
NCT05052983
Phase
PHASE3
Status
Completed

Conditions

  • Prurigo Nodularis

Eligibility Criteria

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

Interventions

  • Nemolizumab — DRUG
    Participants received either 1 \[30 milligram (mg)\] or 2 (2\*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by interactive response technology (IRT).
  • Placebo — DRUG
    Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo every 4 weeks for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by IRT.

Study Details

The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.

Key Dates

Start date
Jan 24, 2022
Status verified
Sep 2024
Primary completion
Sep 11, 2023
Completion
Sep 11, 2023

Study Design

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

Arms

  • Experimental: Nemolizumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria [ Time Frame: Baseline up to Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Galderma Investigational Site 8521Saint JosephMissouri64506-

Find similar trials in Saint Joseph, MO

By research site
Galderma Investigational· Saint Joseph, MO

Related Studies