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

Prurigo Nodularis Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks in Subjects With Prurigo Nodularis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052983
• Other study ID #: RD.06.SPR.203890
• Secondary ID: 2021-003928-32
• Status: Completed
• Phase: Phase 3
• Start date: January 23, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: February 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants who achieved a clinical response at Week 52 of the LTE study

RD.06.SPR.202699, defined as:

1. IGA score of 0 (clear) or 1 (almost clear) AND

2. =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 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

2. Participants with uninterrupted dosing of nemolizumab in the LTE study RD.06.SPR.202699 for 3 months before the Week 52 visit

3. 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

4. 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 subject and/or her partner are defined in the Protocol

5. Female participants of non-childbearing potential must meet one of the following

criteria:

1. 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

2. Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study

6. 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 subject using an electronic handheld device provided for this study.

7. Understand and sign an ICF before any investigational procedure(s) are performed

Exclusion Criteria:

1. Participants who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the Investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant

2. Body weight less than (<) 30 kg (kilogram)

3. Receipt of prohibited medications, including rescue therapy, in the LTE study RD.06.SPR.202699 within 6 months of the Week 52 visit

4. Pregnant women (positive pregnancy test result at baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study

5. Any medical or psychological condition that may put the subject 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)

6. Planning or expected to have a major surgical procedure during the clinical study

7. Participants unwilling to refrain from using prohibited medications during the clinical study

8. History of alcohol or substance abuse within 6 months of baseline

9. Participants with confirmed or suspected COVID-19 infection within 2 weeks before baseline

10. Any condition the Investigator deems incompatible with participant participation in the study

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• Nemolizumab
Participants will receive either 1 [30 milligram (mg)] or 2 (2×30 mg) subcutaneous injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants will receive 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
Participants will receive either 1 (30 mg) or 2 (2x30 mg) subcutaneous injection(s) of placebo every 4 weeks for a period of 24 weeks (with last injection at Week 20). Participants will receive the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by IRT.

Locations

Country	Name	City	State
Austria	Galderma Investigational Site 5471	Graz
Austria	Galderma Investigational Site 6158	Vienna
France	Galderma Investigational Site 5104	Brest
France	Galderma Investigational Site 5140	Nice
France	Galderma Investigational Site 6168	Valence
Germany	Galderma Investigational Site 5604	Berlin
Germany	Galderma Investigational Site 6082	Bonn
Germany	Galderma Investigational Site 6210	Heidelberg
Korea, Republic of	Galderma Investigational Site 6098	Ansan
Poland	Galderma Investigational Site 6052	Kraków
Poland	Galderma Investigational Site 6237	Ostrowiec Swietokrzyski
Poland	Galderma Investigational Site 5495	Rzeszów
Switzerland	Galderma Investigational Site 5069	Lausanne
United States	Galderma Investigational Site 8521	Saint Joseph	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Korea, Republic of,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in (Weekly Average of the) Peak Pruritus (PP) Numeric Rating Scale (NRS) Score >=4 Points from Baseline	Pruritus NRS is a scale that will be 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 scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.	Baseline up to Week 24
Primary	Increase in Investigator Global Assessment (IGA) Score >=2 Points From Baseline	IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).	Baseline up to Week 24
Secondary	Proportion 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 will be 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 scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.	Baseline up to Week 24
Secondary	Proportion of Participants Maintaining Investigator Global Assessment (IGA) Success, Defined as IGA Score of 0 (Clear) or 1 (Almost Clear) 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 will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).	Baseline up to Week 24
Secondary	Proportion of Participants With Increase in Investigator Global Assessment (IGA) >= 2 Points From Baseline 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 will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).	Baseline up to Week 24
Secondary	Absolute and Percent Change from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Each Scheduled Visit	Pruritus NRS is a scale that will be 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 scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.	Baseline up to Week 24
Secondary	Absolute and Percent Change from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Each Scheduled Visit	An NRS relating to sleep disturbance (SD NRS) will be completed by the participants to report the degree of their sleep loss related to PN. The SD NRS will ask for a unit score on an 11-point scale (0 to 10). The question asked will be: "On a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)", how would you rate your sleep last night?"	Baseline up to Week 24
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 and Week 24	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).	Baseline, Week 16 and 24
Secondary	Incidence and Severity of Adverse Events (AEs), Including Treatment-Emergent AEs (TEAEs), Adverse Events of Special Interest (AESIs), Serious AEs (SAEs), Treatment-Related AEs, and AEs that Lead to Discontinuation		Baseline up to Week 32