Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004789-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab | Experimental | Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. |
|
| Placebo | Placebo Comparator | Participants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemolizumab | Drug | Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Baseline, Week 16 |
| Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
Not provided
Inclusion Criteria:
Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
Severe pruritus was defined as follows on the PP NRS:
Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Fountain Valley | California | 92708 | United States | ||
| Galderma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888917 | Result | Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333. | |
| 40266487 |
Not provided
Not provided
Qualified researchers may request access to anonymized data sets from which results presented are derived.
Data availability will begin 6 months after approval of the indication by a regulatory body.
Data availability will end 5 years from publication of the primary study results article.
Data will be made available to qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. Proposals should be directed to clinical.studies@galderma.com
Not provided
A total of 274 participants were randomized and treated (183 participants in Nemolizumab and 91 participants in Placebo group) received treatment in this study.
The study was conducted at 55 sites in 9 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nemolizumab | Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2021 | Apr 16, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants received matching placebo as SC injection. |
|
| Baseline, Week 4 |
| Number of Participants With PP NRS < 2 at Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Week 16 |
| Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. 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 prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Baseline, Week 16 |
| Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. 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 prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Baseline, Week 4 |
| Number of Participants With PP NRS < 2 at Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | Week 4 |
| Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug. | From baseline up to end of treatment period (16 Weeks) |
| San Diego |
| California |
| 92123 |
| United States |
| Galderma Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| Galderma Investigational Site | Aventura | Florida | 33180 | United States |
| Galderma Investigational Site | Miami | Florida | 33136 | United States |
| Galderma Investigational Site | North Miami Beach | Florida | 33162-4708 | United States |
| Galderma Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Galderma Investigational Site | Chicago | Illinois | 60602 | United States |
| Galderma Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Galderma Investigational Site | Louisville | Kentucky | 40241 | United States |
| Galderma Investigational Site | Boston | Massachusetts | 02111 | United States |
| Galderma Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| Galderma Investigational Site | New York | New York | 10021 | United States |
| Galderma Investigational Site | Cincinnati | Ohio | 45627 | United States |
| Galderma Investigational Site | Dublin | Ohio | 43016 | United States |
| Galderma Investigational Site | Anderson | South Carolina | 29621 | United States |
| Galderma Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| Galderma Investigational Site | Dallas | Texas | 75230 | United States |
| Galderma Investigational Site | Dripping Springs | Texas | 78620 | United States |
| Galderma Investigational Site | Pflugerville | Texas | 78660 | United States |
| Galderma Investigational Site | Webster | Texas | 77004 | United States |
| Galderma Investigational Site | Morgantown | West Virginia | 26505 | United States |
| Galderma Investigational Site | Brussels | 1200 | Belgium |
| Galderma Investigational Site | Ghent | 9000 | Belgium |
| Galderma Investigational Site | Jette | 1090 | Belgium |
| Galderma Investigational Site | Leuven | 3000 | Belgium |
| Galderma Investigational Site | Liège | 4000 | Belgium |
| Galderma Investigational Site | North York | Ontario | M2M 4J5 | Canada |
| Galderma Investigational Site | Bathurst | M3H 5Y8 | Canada |
| Galderma Investigational Site | Calgary | T2G 1B1 | Canada |
| Galderma Investigational Site | London | N6H 5L5 | Canada |
| Galderma Investigational Site | Markham | L3P 1X2 | Canada |
| Galderma Investigational Site | Bordeaux | 33000 | France |
| Galderma Investigational Site | Brest | 29200 | France |
| Galderma Investigational Site | Lille | 59037 | France |
| Galderma Investigational Site | Nantes | 44093 | France |
| Galderma Investigational Site | Nice | 06202 | France |
| Galderma Investigational Site | Paris | 75020 | France |
| Galderma Investigational Site | Paris | 75475 | France |
| Galderma Investigational Site | Pierre-Bénite | 69495 | France |
| Galderma Investigational Site | Rouen | 76000 | France |
| Galderma Investigational Site | Saint-Etienne | 42055 | France |
| Galderma Investigational Site | Toulouse | 31000 | France |
| Galderma Investigational Site | Valence | 26953 | France |
| Galderma Investigational Site | Groningen | 9713 | Netherlands |
| Galderma Investigational Site | Utrecht | 3508 | Netherlands |
| Galderma Investigational Site | Bydgoszcz | 85-065 | Poland |
| Galderma Investigational Site | Chorzów | 41-500 | Poland |
| Galderma Investigational Site | Krakow | 31-559 | Poland |
| Galderma Investigational Site | Lodz | 90-265 | Poland |
| Galderma Investigational Site | Lodz | 90-436 | Poland |
| Galderma Investigational Site | Lublin | 20-081 | Poland |
| Galderma Investigational Site | Olsztyn | 10-229 | Poland |
| Galderma Investigational Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Galderma Investigational Site | Rzeszów | 35-055 | Poland |
| Galderma Investigational Site | Szczecin | 71-434 | Poland |
| Galderma Investigational Site | Warsaw | 01-518 | Poland |
| Galderma Investigational Site | Warsaw | 01-817 | Poland |
| Galderma Investigational Site | Warsaw | 02-507 | Poland |
| Galderma Investigational Site | Warsaw | 02-758 | Poland |
| Galderma Investigational Site | Wroclaw | 50-566 | Poland |
| Galderma Investigational Site | Wroclaw | 51-318 | Poland |
| Galderma Investigational Site | Gyeonggi-do | 15355 | South Korea |
| Galderma Investigational Site | Seoul | 02841 | South Korea |
| Galderma Investigational Site | Seoul | 03722 | South Korea |
| Galderma Investigational Site | Seoul | 04763 | South Korea |
| Galderma Investigational Site | Seoul | 07441 | South Korea |
| Galderma Investigational Site | Barcelona | 08041 | Spain |
| Galderma Investigational Site | Las Palmas de Gran Canaria | 35019 | Spain |
| Galderma Investigational Site | Bern | 3010 | Switzerland |
| Galderma Investigational Site | Buochs | 6374 | Switzerland |
| Galderma Investigational Site | Lausanne | 1011 | Switzerland |
| Galderma Investigational Site | Sankt Gallen | 9007 | Switzerland |
| Galderma Investigational Site | Weinfelden | 8570 | Switzerland |
| Derived |
| Stander S, Rodriguez DN, Dias-Barbosa C, Filipenko D, Puelles J, Jabbar-Lopez ZK, Piketty C, Wiegmann H, Kwatra SG. Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis. Dermatol Ther (Heidelb). 2025 Jun;15(6):1405-1426. doi: 10.1007/s13555-025-01406-1. Epub 2025 Apr 23. |
| FG001 | Placebo | Participants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nemolizumab | Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. |
| BG001 | Placebo | Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted of all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted of all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted of all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With PP NRS < 2 at Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted all randomized participants. | Posted | Count of Participants | Participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. 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 prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. 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 prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted of all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With PP NRS < 2 at Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. | ITT population consisted all randomized participants. | Posted | Count of Participants | Participants | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug. | Safety population included all randomized participants who received at least 1 administration of study drug. | Posted | Count of Participants | Participants | From baseline up to end of treatment period (16 Weeks) |
|
From baseline up to end of treatment period (16 Weeks)
Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Not provided
| 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 weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. | 0 | 183 | 4 | 183 | 29 | 183 |
| EG001 | Placebo | Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. | 0 | 91 | 5 | 91 | 13 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2022 | Apr 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011536 | Prurigo |
| D009450 | Neurodermatitis |
| D011537 | Pruritus |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612881 | nemolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Others |
|
| Unknown or Not Reported |
|
| North America |
|
| Pacifica |
|
Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH. |
| Superiority |
|
|
|
|
|
|
|
|
|
| OG001 | Placebo | Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. |
|
|
|
| OG001 |
| Placebo |
Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. |
|
|
|
|
|
|
| OG001 | Placebo | Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection. |
|
|