Trial · NCT03985943

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943, Phase 3, Completed, Galderma R&D; results first posted 2024-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Trials, record NCT03985943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03985943

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
NCT number: NCT03985943
Status: Completed
Phases: Phase 3
Enrollment: 941 participants, actual
Lead sponsor: Galderma R&D
Conditions: Moderate-to-Severe Atopic Dermatitis
Interventions: Placebo, Nemolizumab
First posted: 2019-06-14
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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
Primary	Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
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 outcomes

Outcomes18

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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): 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 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.	percentage of subjects	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.	percentage of participants	NUMBER

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	24.6	percentage of participants
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	35.6	percentage of participants
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	21.4	percentage of participants
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	35.5	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	29.0	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	43.5	percentage of participants
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	23.8	percentage of participants
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	41.6	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	17.8	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	42.7	percentage of participants

1 to 10 of 36Source ClinicalTrials.gov

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Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Initial Treatment(Day 1-Week 16 Predose)	STARTED	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	321
Initial Treatment(Day 1-Week 16 Predose)	STARTED	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	620
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)	Safety Population	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	321
Initial Treatment(Day 1-Week 16 Predose)	Safety Population	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	616
Initial Treatment(Day 1-Week 16 Predose)	Safety Population	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W	0
Initial Treatment(Day 1-Week 16 Predose)	Safety Population	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W	0

1 to 10 of 48Source ClinicalTrials.gov

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Adverse events138

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
other	COVID-19	Infections and infestations	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	6	321
other	COVID-19	Infections and infestations	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	10	616
other	COVID-19	Infections and infestations	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W	9	91
other	COVID-19	Infections and infestations	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W	9	90
other	COVID-19	Infections and infestations	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W	6	91
other	COVID-19	Infections and infestations	Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W	10	100
other	Nasopharyngitis	Infections and infestations	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	8	321
other	Nasopharyngitis	Infections and infestations	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	9	616
other	Nasopharyngitis	Infections and infestations	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W	7	91
other	Nasopharyngitis	Infections and infestations	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W	5	90

1 to 10 of 138Source ClinicalTrials.gov

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Adverse 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): Placebo	0	321
Total, all-cause mortality	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	0	616
Total, all-cause mortality	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W	0	91
Total, all-cause mortality	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W	0	90
Total, all-cause mortality	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W	0	91
Total, all-cause mortality	Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W	0	100
Total, other adverse events	Initial Treatment Period (Baseline - Week 16 Predose): Placebo	67	321
Total, other adverse events	Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg	144	616
Total, other adverse events	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W	27	91
Total, other adverse events	Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W	28	90

1 to 10 of 18Source ClinicalTrials.gov

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Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39008191	DERIVED	PubMed
39067461	DERIVED	PubMed
40116983	DERIVED	PubMed
40360966	DERIVED	PubMed
42693785	DERIVED	PubMed
42771135	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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