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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003429-27 | EudraCT Number |
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This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants will receive MSTT1041A |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to MSTT1041A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSTT1041A | Drug | Participants will receive subcutaneous (SC) MSTT1041A |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Total Eczema Area and Severity Index (EASI) Score | The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | Baseline, Week 16 | |
| Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | Baseline, Week 16 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Allergy & Asthma | Birmingham | Alabama | 35209 | United States | ||
| California Allergy and Asthma Medical Group - CRN |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).
Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W. |
| FG001 | Treatment | Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 |
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| Placebo | Drug | Participants will receive SC placebo |
|
| Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | The Peak Pruritis Numerical Rating Scale (NRS) is a single-item patient-reported outcome (PRO) of itch severity rated on a scale of 0-10, with 0 = no itch and 10 = worst itch imaginable for the prior 24-hour period. | Baseline, Week 16 |
| Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | Baseline, Week 16 |
| Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) | SCORAD is a tool used to assess the extent and severity of eczema based on three aspects of disease severity: extent, intensity, and a subjective (PRO) symptoms. A total score (0-103) is calculated, with higher scores indicating a higher extent and severity of symptoms. | Baseline, Week 16 |
| Percentage of Participants With Adverse Events (AE) | Up to Week 24 |
| Serum Concentrations of MSTT1041A | At pre-defined intervals from baseline up to Week 24 |
| Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) | Up to Week 24 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Jonathan Corren MD, Inc. | Los Angeles | California | 90025 | United States |
| Asthma & Allergy; Associates, P.C. | Colorado Springs | Colorado | 80907 | United States |
| South Coast Research Center, Inc. | Miami | Florida | 33136 | United States |
| Harmony Clinical Research, Inc | North Miami Beach | Florida | 33162 | United States |
| GCP Global Clinical Professionals | St. Petersburg | Florida | 33702 | United States |
| Forward Clinical Trials | Tampa | Florida | 33624 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| Midwest Sinus Allergy and Asthma - CRN | Normal | Illinois | 61761 | United States |
| Dermatology Specialists Research, LLC | Louisville | Kentucky | 40241 | United States |
| Clinical Research Consortium Nevada | Las Vegas | Nevada | 89119 | United States |
| Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS | Hackensack | New Jersey | 07601 | United States |
| Vital Prospects Clinical Research Institute PC - CRN | Tulsa | Oklahoma | 74136 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Centrum Medyczne ALL-MED | Krakow | 30-033 | Poland |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | 90-153 | Poland |
| Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii | Rzeszów | 35-055 | Poland |
| Laser Clinic | Szczecin | 70-322 | Poland |
| Wro Medica | Wroc?aw | 51-685 | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W. |
| BG001 | Treatment | Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W). |
| 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, Categorical | Count of Participants | Participants |
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| 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 | Percent Change of Total Eczema Area and Severity Index (EASI) Score | The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72. | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Mean | Standard Error | Percentage | Baseline, Week 16 |
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| Secondary | Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Number | Percentage | Baseline, Week 16 |
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| Secondary | Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Number | Percentage | Baseline, Week 16 |
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| Secondary | Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | The Peak Pruritis Numerical Rating Scale (NRS) is a single-item patient-reported outcome (PRO) of itch severity rated on a scale of 0-10, with 0 = no itch and 10 = worst itch imaginable for the prior 24-hour period. | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Mean | Standard Error | Percentage | Baseline, Week 16 |
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| Secondary | Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Mean | Standard Error | Percentage | Baseline, Week 16 |
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| Secondary | Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) | SCORAD is a tool used to assess the extent and severity of eczema based on three aspects of disease severity: extent, intensity, and a subjective (PRO) symptoms. A total score (0-103) is calculated, with higher scores indicating a higher extent and severity of symptoms. | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Posted | Mean | Standard Error | Percentage | Baseline, Week 16 |
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| Secondary | Percentage of Participants With Adverse Events (AE) | Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Serum Concentrations of MSTT1041A | PK population: The PK population included participants from the safety population with at least one available post-study treatment PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | At pre-defined intervals from baseline up to Week 24 |
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| Secondary | Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) | Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received. | Posted | Number | Participants | Up to Week 24 |
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Up to Week 24
The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.
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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 | Placebo | Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W. | 0 | 31 | 0 | 31 | 8 | 31 |
| EG001 | Treatment | Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W). | 0 | 34 | 1 | 34 | 3 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic aneurysm | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| Mar 2, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000711667 | astegolimab |
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| >=65 years |
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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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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 1 Visit 2/prior to infusion |
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| Week 1 Visit 3/prior to infusion |
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| Week 4 Visit 5/prior to infusion |
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| Week 8 Visit 7/prior to infusion |
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| Week 12 Visit 9/prior to infusion |
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| Week 16 Visit 11 |
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| Subject disposition - period completion/early discontinuation |
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