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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
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).
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.
Galderma Investigational Site 8521
Saint Joseph, Missouri, United States
Galderma Investigational Site 5471
Graz, Austria
Galderma Investigational Site 6158
Vienna, Austria
Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria
Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication
Time frame: Baseline up to Week 24
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear).
Time frame: Baseline up to Week 24
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit
Pruritus NRS is a scale that is used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Time frame: Baseline up to Week 24
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Galderma Investigational Site 5104
Brest, France
Galderma Investigational Site 5140
Nice, France
Galderma Investigational Site 6168
Valence, France
Galderma Investigational Site 5604
Berlin, Germany
Galderma Investigational Site 6082
Bonn, Germany
Galderma Investigational Site 6210
Heidelberg, Germany
Galderma Investigational Site 6052
Krakow, Poland
...and 4 more locations