Trial · NCT03989349
Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
NCT03989349, Phase 3, Completed, Galderma R&D; results first posted 2024-08-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Trials, record NCT03989349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03989349
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
- NCT number
- NCT03989349
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 787 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Interventions
- Placebo, Nemolizumab
- First posted
- 2019-06-18
- Last updated
- 2024-08-14
- Results first posted
- 2024-08-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | Week 16 | IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Primary | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | Week 16 | IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Primary | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | Week 16 | EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Primary | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | Week 16 | EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. |
| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. |
| Secondary | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Secondary | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Secondary | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | Week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Secondary | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | Week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | Week 16 | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | Week 16 | Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | Week 16 | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | Week 16 | Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | Week 16 | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | Week 16 | Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | Week 16 | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | Week 16 | Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | Week 16 | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | Week 16 | Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 37.7 | percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 26.0 | percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 36.7 | percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 22.0 | percentage of participants | ||
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 42.1 | percentage of participants | ||
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 30.2 | percentage of participants | ||
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 41.1 | percentage of participants | ||
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 25.0 | percentage of participants | ||
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 41.0 | percentage of participants | ||
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 18.1 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 522 | |
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 265 | |
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W | 0 | |
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W | 0 | |
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W | 0 | |
| Initial Treatment(Day 1-Week 16 Predose) | STARTED | Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W | 0 | |
| Initial Treatment(Day 1-Week 16 Predose) | Treated | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 519 | |
| Initial Treatment(Day 1-Week 16 Predose) | Treated | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 263 | |
| Initial Treatment(Day 1-Week 16 Predose) | Treated | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W | 0 | |
| Initial Treatment(Day 1-Week 16 Predose) | Treated | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events192
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 | Dermatitis atopic | Skin and subcutaneous tissue disorders | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 34 | 519 | 42 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 15 | 263 | 15 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W | 6 | 79 | 7 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W | 3 | 77 | 4 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W | 6 | 77 | 7 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W | 5 | 84 | 5 |
| other | Nasopharyngitis | Infections and infestations | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 19 | 519 | 24 |
| other | Nasopharyngitis | Infections and infestations | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 12 | 263 | 13 |
| other | Nasopharyngitis | Infections and infestations | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W | 7 | 79 | 12 |
| other | Nasopharyngitis | Infections and infestations | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W | 3 | 77 | 6 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 0 | 519 |
| Total, all-cause mortality | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 0 | 263 |
| Total, all-cause mortality | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W | 0 | 79 |
| Total, all-cause mortality | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W | 0 | 77 |
| Total, all-cause mortality | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W | 0 | 77 |
| Total, all-cause mortality | Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W | 0 | 84 |
| Total, other adverse events | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | 71 | 519 |
| Total, other adverse events | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | 40 | 263 |
| Total, other adverse events | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W | 17 | 79 |
| Total, other adverse events | Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W | 11 | 77 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03989349
GET https://conductscience.org/api/trials/v1/NCT03989349/results?page=2