Prurigo Nodularis
Conditions
Brief summary
The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
Interventions
DRUGNemolizumab
Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites) * Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection * Participant 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
Exclusion criteria
* Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant * Body weight \< 30 kg * Pregnant women (positive pregnancy test result at screening or baseline visit or re-entry Week R0 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 (example, 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 prior to the screening visit or re-entry Week R0 visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) by Severity | Up to 192 weeks | Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184 | Baseline up to Week 184 | Percentage of participants with an improvement of \>= 4 from baseline in PP NRS up to Week 184 will be reported. The PP NRS has a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percentage of Participants with Low Disease Activity State up to Week 184 | Up to Week 184 | Percentage of participants with low disease activity state (that is, IGA less than or equal to \[\<=\]2) up to Week 184 will be reported. |
| Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184 | Up to Week 184 | Prurigo Activity Score (PAS) will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts. Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 184 will be reported. |
| Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184 | Up to Week 184 | PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed. Percentage of healed prurigo lesions (PAS item 5b) up to Week 184 will be reported. |
| Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184 | Baseline up to Week 184 | Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported. |
| Percentage of Participants with PP NRS <2 up to Week 184 | Up to Week 184 | Percentage of participants with PP NRS \<2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percent Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Absolute Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52 | Up to Week 52 | Percentage of participants with AP NRS less than (\<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52 | Up to Week 52 | Percentage of participants with an improvement of \>=4 from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percent Change from Baseline in AP NRS up to Week 52 | Up to Week 52 | Percent change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Absolute Change from Baseline in AP NRS up to Week 52 | Up to Week 52 | Absolute change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being no itch and 10 being worst itch imaginable. |
| Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184 | Up to Week 184 | Percentage of participants with an IGA success (defined as IGA of 0 \[Clear\] or 1 \[Almost clear\]) up to Week 184 will be reported. |
| Percent Change from Baseline in SD NRS up to Week 184 | Up to Week 184 | Percent change from baseline in SD NRS up to Week 184 will be reported. SD NRS has 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). |
| Absolute Change from Baseline in SD NRS up to Week 184 | Up to Week 184 | Absolute change from baseline in SD NRS up to Week 184 will be reported. SD NRS has 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). |
| Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184 | Baseline up to Week 184 | Change from baseline in PN-associated pain frequency up to Week 184 will be reported. The pain frequency will be assessed on a scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week. |
| Change from Baseline in PN-associated Pain Intensity up to Week 184 | Baseline up to Week 184 | Change from baseline in PN-associated pain intensity up to Week 184 will be reported. The pain intensity will be assessed on a scale of 0 to 10, with 0 being no pain and 10 being the worst unbearable pain. |
| Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52 | Up to Week 52 | Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported. |
| Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52 | Up to Week 52 | Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) up to Week 52 will be reported. |
| Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184 | Baseline up to Week 184 | Percentage of participants with a change of \>=4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 184 will be reported. 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). A higher total score indicates a poorer quality of life (QoL). |
| Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184 | Baseline up to Week 184 | Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184 will be reported. The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point Visual Analog Scale (VAS) with 0 being Worst imaginable health state and 100 being Best imaginable health state. |
| Time to Permanent Study Drug Discontinuation | Baseline to 184 weeks | — |
| Time to Rescue Therapy | Baseline to 184 weeks | — |
| Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment | Baseline up to 184 weeks | — |
| Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184 | Up to Week 184 | Percentage of participants with an improvement of \>=4 from baseline in Sleep Disturbance (SD) NRS up to Week 184 will be reported. SD NRS has 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). |
Countries
Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed