Prurigo Nodularis
Conditions
Keywords
Prurigo Nodularis, Nemolizumab, CD14152
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.
Interventions
DRUGPlacebo
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.
DRUGNemolizumab
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).
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as: 1. Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND 2. 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 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 participant 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 participant using an electronic handheld device provided for this study. 7. Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed
Exclusion criteria
1. 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 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 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) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | Baseline up to Week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Baseline up to Week 24 | 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). |
| 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 | 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. |
Countries
Austria, France, Germany, Poland, South Korea, Switzerland, United States
Participant flow
Recruitment details
This study was conducted at 14 study sites in 7 countries from 24 January 2022 to 11 September 2023.
Pre-assignment details
A total of 34 participants from long-term extension (LTE) study RD.06.SPR.202699 (NCT05052983) were enrolled and treated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Nemolizumab Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab 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 (NCT05052983), as assigned by IRT. | 18 |
| Placebo Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo 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 (NCT05052983), as assigned by IRT. | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lack of Efficacy | 3 | 12 |
Baseline characteristics
| Characteristic | Nemolizumab | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 14.06 | 59.5 years STANDARD_DEVIATION 13.56 | 59.1 years STANDARD_DEVIATION 13.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 28 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 11 / 18 | 10 / 16 |
| serious Total, serious adverse events | 2 / 18 | 0 / 16 |
Outcome results
Primary
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
Population: ITT population included all randomized participants. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nemolizumab | Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | NA Days |
| Placebo | Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | 112.50 Days |
Secondary
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
Population: ITT population included all randomized participants. Here, number analyzed signifies participants who were evaluable for given categories. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 8 | 82.4 Percentage of Participants |
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 16 | 81.3 Percentage of Participants |
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 4 | 88.2 Percentage of Participants |
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 20 | 86.7 Percentage of Participants |
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 12 | 88.2 Percentage of Participants |
| Nemolizumab | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 24 | 85.7 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 24 | 60.0 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 4 | 86.7 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 8 | 81.3 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 12 | 53.3 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 16 | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | At Week 20 | 57.1 Percentage of Participants |
Secondary
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
Population: ITT population included all randomized participants. Here, number analyzed signifies participants who were evaluable for given categories. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 4 | 0 Percentage of Participants |
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 8 | 0 Percentage of Participants |
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 12 | 0 Percentage of Participants |
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 16 | 6.7 Percentage of Participants |
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 20 | 0 Percentage of Participants |
| Nemolizumab | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 24 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 20 | 33.3 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 4 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 16 | 33.3 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 8 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 24 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | At Week 12 | 16.7 Percentage of Participants |