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

NCT05052983 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: RD.06.SPR.2038902021-003928-32
• Study Type: interventional
• Target: 34
• Locations: 7 countries
• Sites: 14

Brief Summary

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.

Conditions

Prurigo Nodularis

Keywords

Prurigo Nodularis; Nemolizumab; CD14152

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline up to Week 24

Secondary Outcomes (2)

• Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit

  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

  Baseline up to Week 24

Study Arms (2)

Nemolizumab

EXPERIMENTAL

Drug: Nemolizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

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).

Also known as: CD14152

Nemolizumab

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as:
• Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND
• Greater than or equal to (\>=)4-point improvement in weekly average of PP NRS score from baseline of the lead-in study Note: Lead-in study baseline is defined as baseline Peak Pruritus Numerical Rating Scale (PP NRS) score in the Phase 3 studies RD.06.SPR.202685 or RD.06.SPR.203065 for participants who rolled over into the LTE from these studies. For participants who entered the LTE study from the Phase 2 study RD.03.SPR.115828, the baseline PP NRS score at entry into the LTE study RD.06.SPR.202699 will be used
• Participants with uninterrupted dosing of nemolizumab in the LTE study RD.06.SPR.202699 for 3 months before the Week 52 visit
• Participants willing and able to transfer into the study at the time of completion of the Week 52 visit in the LTE study RD.06.SPR.202699
• Female participants of childbearing potential (i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Adequate and approved methods of contraception applicable for the participant and/or her partner are defined in the Protocol
• Female participants of non-childbearing potential must meet one of the following criteria:
• Absence of menstrual bleeding for 1 year prior to baseline without any other medical reason, confirmed with follicle-stimulating hormone (FSH) level in the postmenopausal range
• Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study
• Participants willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study.
• Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

You may not qualify if:

• Participants who, during their participation in a prior nemolizumab study, experienced an adverse event which in the opinion of the Investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
• Body weight less than (\<) 30 kg (kilogram)
• Receipt of prohibited medications, including rescue therapy, in the LTE study RD.06.SPR.202699 within 6 months of the Week 52 visit
• Pregnant women (positive pregnancy test result at baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study
• Any medical or psychological condition that may put the participant at significant risk according to the Investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (e.g., poor venous access or needle-phobia)
• Planning or expected to have a major surgical procedure during the clinical study
• Participants unwilling to refrain from using prohibited medications during the clinical study
• History of alcohol or substance abuse within 6 months of baseline
• Participants with confirmed or suspected COVID-19 infection within 2 weeks before baseline
• Any condition the Investigator deems incompatible with participant participation in the study

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (14)

Galderma Investigational Site 8521

Saint Joseph, Missouri, 64506, United States

Location

Galderma Investigational Site 5471

Graz, 8036, Austria

Location

Galderma Investigational Site 6158

Vienna, 1220, Austria

Location

Galderma Investigational Site 5104

Brest, 29200, France

Location

Galderma Investigational Site 5140

Nice, 06200, France

Location

Galderma Investigational Site 6168

Valence, 26000, France

Location

Galderma Investigational Site 5604

Berlin, 12203, Germany

Location

Galderma Investigational Site 6082

Bonn, 53127, Germany

Location

Galderma Investigational Site 6210

Heidelberg, 69115, Germany

Location

Galderma Investigational Site 6052

Krakow, 31-559, Poland

Location

Galderma Investigational Site 6237

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Galderma Investigational Site 5495

Rzeszów, 35-055, Poland

Location

Galderma Investigational Site 6098

Ansan, 15355, South Korea

Location

Galderma Investigational Site 5069

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

nemolizumab

Results Point of Contact

• Title: Sponsor
• Organization: Galderma Research & Development

clinical.studies@galderma.com

(817) 961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: January 24, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); PL (3); KR (1); CH (1); US (1); DE (3); FR (3)