Trial · NCT03747575
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
NCT03747575, Phase 2, Completed, Genentech, Inc.; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis. Trials, record NCT03747575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03747575
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT03747575
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Atopic Dermatitis
- Interventions
- MSTT1041A, Placebo
- First posted
- 2018-11-20
- Last updated
- 2023-05-06
- Other registries' IDs
- eudract:2018-003429-27
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change of Total Eczema Area and Severity Index (EASI) Score | Baseline, Week 16 | 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. |
| Secondary | Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | Baseline, Week 16 | |
| Secondary | Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | Baseline, Week 16 | |
| Secondary | Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | Baseline, Week 16 | 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. |
| Secondary | Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | Baseline, Week 16 | |
| Secondary | Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) | Baseline, Week 16 | 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. |
| Secondary | Percentage of Participants With Adverse Events (AE) | Up to Week 24 | |
| Secondary | Serum Concentrations of MSTT1041A | At pre-defined intervals from baseline up to Week 24 | |
| Secondary | Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) | Up to Week 24 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change of Total Eczema Area and Severity Index (EASI) Score | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | MEAN |
| SECONDARY | Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | NUMBER |
| SECONDARY | Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | NUMBER |
| SECONDARY | Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | MEAN |
| SECONDARY | Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | MEAN |
| SECONDARY | Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) | Baseline, Week 16 | ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization. | Percentage | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events (AE) | Up to Week 24 | Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentrations of MSTT1041A | At pre-defined intervals from baseline up to Week 24 | PK population: The PK population included participants from the safety population with at least one available post-study treatment PK sample. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) | Up to Week 24 | Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change of Total Eczema Area and Severity Index (EASI) Score | Treatment | -51.47 | Standard Error 8.639 | Percentage | |
| Percent Change of Total Eczema Area and Severity Index (EASI) Score | Placebo | -58.24 | Standard Error 9.092 | Percentage | |
| Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | Treatment | 15.2 | Percentage | ||
| Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 | Placebo | 6.3 | Percentage | ||
| Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | Treatment | 27.3 | Percentage | ||
| Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score | Placebo | 18.8 | Percentage | ||
| Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | Treatment | -31.22 | Standard Error 7.376 | Percentage | |
| Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) | Placebo | -39.43 | Standard Error 7.839 | Percentage | |
| Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | Treatment | -42.23 | Standard Error 8.637 | Percentage | |
| Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement | Placebo | -38.87 | Standard Error 9.134 | Percentage |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | STARTED | Treatment | 33 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | Treatment | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Treatment | 7 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 31 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment | 0 | 34 | 0 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 31 | 5 |
| other | Nasopharyngitis | Infections and infestations | Treatment | 0 | 34 | 0 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Placebo | 5 | 31 | 6 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Treatment | 3 | 34 | 3 |
| serious | Aortic aneurysm | Vascular disorders | Placebo | 0 | 31 | 0 |
| serious | Aortic aneurysm | Vascular disorders | Treatment | 1 | 34 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 31 |
| Total, all-cause mortality | Treatment | 0 | 34 |
| Total, other adverse events | Placebo | 8 | 31 |
| Total, other adverse events | Treatment | 3 | 34 |
| Total, serious adverse events | Placebo | 0 | 31 |
| Total, serious adverse events | Treatment | 1 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Placebo: Percentage of Participants With Adverse Events (AE) | Trial comparisons |
| Treatment vs Placebo: Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) | Trial comparisons |
| Treatment vs Placebo: deaths from any cause | Trial comparisons |
| Treatment vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03747575
GET https://conductscience.org/api/trials/v1/NCT03747575/results?page=2