Trial · NCT03100344
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
NCT03100344, Phase 2, Completed, Galderma R&D; results first posted 2019-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-ranging Study of Nemolizumab in Atopic Dermatitis. Trials, record NCT03100344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03100344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-ranging Study of Nemolizumab in Atopic Dermatitis
- NCT number
- NCT03100344
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 226 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Atopic Dermatitis
- Interventions
- Nemolizumab, Placebo
- First posted
- 2017-04-04
- Last updated
- 2019-10-22
- Results first posted
- 2019-10-22
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | From Baseline to Week 24 | EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. |
| Secondary | Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Week 24 | The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome. |
| Secondary | Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 | From Week 1 to Week 24 | 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. |
| Secondary | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | SCORAD ranges from 0 to 103 and has three components: extent (body surface area \[BSA\]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome. |
| Secondary | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | SCORAD ranges from 0 to 103 and has three components: extent (body surface area \[BSA\]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome. |
| Secondary | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | 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 questions 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'. Higher scores indicate worse outcome. |
| Secondary | Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | 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 questions 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'. Higher scores indicate worse outcome. |
| Secondary | Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 | From Week 1 to Week 24 | IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. |
| Secondary | Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 | From Week 1 to Week 24 | EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. |
| Secondary | Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 | From Week 1 to Week 24 | EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome. |
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 | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | From Baseline to Week 24 | All participants in intent-to-treat (ITT) population who received at least one dose of study drug. | percentage change | MEAN |
| SECONDARY | Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Week 24 | ITT population: All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 | From Week 1 to Week 24 | ITT population: All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | ITT population: All randomized participants. | Percentage change | MEAN |
| SECONDARY | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | ITT population: All randomized participants. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | ITT population: All randomized participants. | Percentage change | MEAN |
| SECONDARY | Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | ITT population: All randomized participants. | units on a scale | MEAN |
| SECONDARY | Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 | From Week 1 to Week 24 | ITT population: All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 | From Week 1 to Week 24 | ITT Population:All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 | From Week 1 to Week 24 | ITT Population: All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group404
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | Placebo | -58.4 | Standard Deviation 31.99 | percentage change | |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | Nemolizumab (10 mg) | -72.2 | Standard Deviation 25.96 | percentage change | |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | Nemolizumab (30 mg) | -73.4 | Standard Deviation 29.67 | percentage change | |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | Nemolizumab (90 mg) | -69.2 | Standard Deviation 31.06 | percentage change | |
| Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Placebo | 13 | Participants | ||
| Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Nemolizumab (10 mg) | 23 | Participants | ||
| Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Nemolizumab (30 mg) | 31 | Participants | ||
| Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Nemolizumab (90 mg) | 20 | Participants | ||
| Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 | Placebo | Week 1 | 3 | Participants | |
| Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 | Nemolizumab (10 mg) | Week 1 | 9 | Participants |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 57 | |
| Overall Study | STARTED | Nemolizumab (10 mg) | 55 | |
| Overall Study | STARTED | Nemolizumab (30 mg) | 57 | |
| Overall Study | STARTED | Nemolizumab (90 mg) | 57 | |
| Overall Study | COMPLETED | Placebo | 43 | |
| Overall Study | COMPLETED | Nemolizumab (10 mg) | 44 | |
| Overall Study | COMPLETED | Nemolizumab (30 mg) | 50 | |
| Overall Study | COMPLETED | Nemolizumab (90 mg) | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Nemolizumab (10 mg) | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 | Nasopharyngitis | Infections and infestations | Placebo | 12 | 56 | |
| other | Nasopharyngitis | Infections and infestations | Nemolizumab (10 mg) | 18 | 55 | |
| other | Nasopharyngitis | Infections and infestations | Nemolizumab (30 mg) | 14 | 57 | |
| other | Nasopharyngitis | Infections and infestations | Nemolizumab (90 mg) | 13 | 57 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 56 | |
| other | Upper respiratory tract infection | Infections and infestations | Nemolizumab (10 mg) | 4 | 55 | |
| other | Upper respiratory tract infection | Infections and infestations | Nemolizumab (30 mg) | 6 | 57 | |
| other | Upper respiratory tract infection | Infections and infestations | Nemolizumab (90 mg) | 4 | 57 | |
| other | Sinusitis | Infections and infestations | Placebo | 0 | 56 | |
| other | Sinusitis | Infections and infestations | Nemolizumab (10 mg) | 4 | 55 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 56 |
| Total, all-cause mortality | Nemolizumab (10 mg) | 1 | 55 |
| Total, all-cause mortality | Nemolizumab (30 mg) | 0 | 57 |
| Total, all-cause mortality | Nemolizumab (90 mg) | 0 | 57 |
| Total, other adverse events | Placebo | 43 | 56 |
| Total, other adverse events | Nemolizumab (10 mg) | 47 | 55 |
| Total, other adverse events | Nemolizumab (30 mg) | 47 | 57 |
| Total, other adverse events | Nemolizumab (90 mg) | 47 | 57 |
| Total, serious adverse events | Placebo | 1 | 56 |
| Total, serious adverse events | Nemolizumab (10 mg) | 3 | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT03100344
GET https://conductscience.org/api/trials/v1/NCT03100344/results?page=2