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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003928-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Participants who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as:
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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site 8521 | Saint Joseph | Missouri | 64506 | United States | ||
| Galderma Investigational Site 5471 |
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A total of 34 participants from long-term extension (LTE) study RD.06.SPR.202699 (NCT05052983) were enrolled and treated in this study.
This study was conducted at 14 study sites in 7 countries from 24 January 2022 to 11 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemolizumab | 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 (NCT05052983), as assigned by interactive response technology (IRT). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2023 | Sep 10, 2024 |
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| 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. |
|
| 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. | Baseline up to Week 24 |
| Graz |
| 8036 |
| Austria |
| Galderma Investigational Site 6158 | Vienna | 1220 | Austria |
| Galderma Investigational Site 5104 | Brest | 29200 | France |
| Galderma Investigational Site 5140 | Nice | 06200 | France |
| Galderma Investigational Site 6168 | Valence | 26000 | France |
| Galderma Investigational Site 5604 | Berlin | 12203 | Germany |
| Galderma Investigational Site 6082 | Bonn | 53127 | Germany |
| Galderma Investigational Site 6210 | Heidelberg | 69115 | Germany |
| Galderma Investigational Site 6052 | Krakow | 31-559 | Poland |
| Galderma Investigational Site 6237 | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Galderma Investigational Site 5495 | Rzeszów | 35-055 | Poland |
| Galderma Investigational Site 6098 | Ansan | 15355 | South Korea |
| Galderma Investigational Site 5069 | Lausanne | 1011 | Switzerland |
| FG001 | 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. |
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| NOT COMPLETED |
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The intent-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
| ITT population included all randomized participants. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Week 24 |
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| 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). | 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. | Posted | Number | Percentage of Participants | Baseline up to Week 24 |
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| 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. | 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. | Posted | Number | Percentage of Participants | Baseline up to Week 24 |
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From Baseline up to end of study (Week 32)
The safety population included all randomized participants who receive at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 18 | 2 | 18 | 11 | 18 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 10 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Extrasystoles | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Thyroid cyst | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Administration site reaction | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Administration site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Febrile infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pustule | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Peak expiratory flow rate decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Urinary lipids present | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Post herpetic neuralgia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
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| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Diabetic macroangiopathy | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | Galderma Research & Development | (817) 961-5000 | clinical.studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2024 | Sep 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000612881 | nemolizumab |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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