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Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nemolizumab

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects ≥ 18 years (or legal age when higher)
Chronic AD, that has been present for at least 2 years before the visit
Eczema Area and Severity Index (EASI) score ≥12
Investigator Global Assessment (IGA) score ≥ 3
AD involvement ≥ 10% of Body Surface Area (BSA)
Severe pruritus on at least 3 of the last 7 days before the visit
Documented recent history (within 6 months before the visit) of inadequate response to topical medications
Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential
- Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

Exclusion Criteria:

Body weight < 45 kg
subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
History of intolerance to low or mid potency TCS or for whom TCS is not advisable

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Nemolizumab (low dose)

Nemolizumab (medium dose)

Nemolizumab (high dose)

Nemolizumab placebo

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Eczema Area and Severity Index (EASI) at 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 Outcome Measures

Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at 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.

Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up 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.

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at 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.

Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24

Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at 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.

Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24

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

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.

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

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.

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

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.

Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up 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.

Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up 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.

Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24

Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Number of Participants With Adverse Events

To evaluate the safety of nemolizumab in participants with moderate-to-severe AD

Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Pruritus NRS is a scale to be 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.

Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average 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.

Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Full Information

NCT ID

NCT03100344

First Posted

March 29, 2017

Last Updated

October 3, 2019

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT03100344

Brief Title

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Official Title

Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 14, 2017 (Actual)

Primary Completion Date

July 19, 2018 (Actual)

Study Completion Date

September 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

Detailed Description

The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Nemolizumab (low dose)

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Nemolizumab (medium dose)

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Nemolizumab (high dose)

Arm Title

Group 4

Arm Type

Placebo Comparator

Arm Description

Nemolizumab placebo

Intervention Type

Drug

Intervention Name(s)

Nemolizumab

Intervention Description

Injection every 4 weeks during 24 weeks (last injection at week 20)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Injection every 4 weeks during 24 weeks (last injection at week 20)

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24

Description

Time Frame

From Baseline to Week 24

Secondary Outcome Measure Information:

Title

Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24

Description

Time Frame

Week 24

Title

Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24

Description

Time Frame

From Week 1 to Week 24

Title

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

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

Description

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.

Time Frame

From Week 1 to Week 24

Title

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

Description

Time Frame

From Week 1 to Week 24

Title

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

Description

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.

Time Frame

From Week 1 to Week 24

Title

Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24

Description

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.

Time Frame

From Week 1 to Week 24

Title

Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24

Description

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.

Time Frame

Week 1 to Week 24

Title

Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24

Description

Time Frame

From Baseline to Week 24

Title

Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Description

Time Frame

At baseline and Week 24

Title

Number of Participants With Adverse Events

Description

To evaluate the safety of nemolizumab in participants with moderate-to-severe AD

Time Frame

From screening to Follow-up visit (Week 32)/Early termination visit

Title

Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Description

Time Frame

Baseline to Week 24

Title

Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Description

Time Frame

Baseline to Week 24

Title

Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24

Description

Time Frame

Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects ≥ 18 years (or legal age when higher) Chronic AD, that has been present for at least 2 years before the visit Eczema Area and Severity Index (EASI) score ≥12 Investigator Global Assessment (IGA) score ≥ 3 AD involvement ≥ 10% of Body Surface Area (BSA) Severe pruritus on at least 3 of the last 7 days before the visit Documented recent history (within 6 months before the visit) of inadequate response to topical medications Female subjects must fulfill one of the criteria below: Female subjects of non-childbearing potential Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration Exclusion Criteria: Body weight < 45 kg subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period History of intolerance to low or mid potency TCS or for whom TCS is not advisable

Facility Information:

Facility Name

Galderma Investigational site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Galderma Investigational site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Galderma Investigational site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

Galderma Investigational site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Galderma Investigational site

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Galderma Investigational site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Galderma Investigational site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Galderma Investigational site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Galderma Investigational site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Galderma Investigational site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Galderma Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Galderma Investigational site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Galderma Investigational site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Galderma Investigational Site

City

Darien

State/Province

Illinois

ZIP/Postal Code

60561

Country

United States

Facility Name

Galderma Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Galderma Investigational site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Galderma Investigational Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

78334

Country

United States

Facility Name

Galderma Investigational site

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

Galderma Investigational site

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Facility Name

Galderma Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Galderma Investigational site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

Galderma Investigational Site

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Galderma Investigational site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Galderma Investigational site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Galderma Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76710

Country

United States

Facility Name

Galderma Investigational site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Galderma Investigational Site

City

Benowa

ZIP/Postal Code

4217 QLD

Country

Australia

Facility Name

Galderma Investigational Site

City

Kogarah

ZIP/Postal Code

NSW 2217

Country

Australia

Facility Name

Galderma Investigational Site

City

Melbourne

ZIP/Postal Code

VIC3002

Country

Australia

Facility Name

Galderma Investigational Site

City

Phillip

ZIP/Postal Code

ACT2606

Country

Australia

Facility Name

Galderma Investigational Site

City

Calgary

ZIP/Postal Code

AB T3A 2N1

Country

Canada

Facility Name

Galderma Investigational Site

City

Markham

ZIP/Postal Code

ON L3P 1X2

Country

Canada

Facility Name

Galderma Investigational Site

City

Oakville

ZIP/Postal Code

ON L6J 7W5

Country

Canada

Facility Name

Galderma Investigational Site

City

Ottawa

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Galderma Investigational Site

City

Ottawa

ZIP/Postal Code

ON K2G 6E2

Country

Canada

Facility Name

Galderma Investigational Site

City

Peterborough

ZIP/Postal Code

K9J

Country

Canada

Facility Name

Galderma Investigational Site

City

Richmond Hill

ZIP/Postal Code

ON L4C

Country

Canada

Facility Name

Galderma Investigational Site

City

Sainte-Foy

ZIP/Postal Code

QC G1V4X7

Country

Canada

Facility Name

Galderma Investigational Site

City

Waterloo

ZIP/Postal Code

ON N2J 1C4

Country

Canada

Facility Name

Galderma Investigational Site

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Galderma Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Galderma Investigational Site

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Galderma Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Galderma Investigational Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Galderma Investigational Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Galderma Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Galderma Investigational Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Galderma Investigational Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Galderma Investigational Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Galderma Investigational Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Galderma Investigational Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Galderma Investigational Site

City

Hannöver

ZIP/Postal Code

30625

Country

Germany

Facility Name

Galderma Investigational Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Galderma Investigational Site

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Facility Name

Galderma Investigational Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Galderma Investigational Site

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Galderma Investigational Site

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Galderma Investigational Site

City

Stuttgart

ZIP/Postal Code

70718

Country

Germany

Facility Name

Galderma Investigational Site

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Galderma Investigational Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Galderma Investigational Site

City

Kraków

ZIP/Postal Code

31-024

Country

Poland

Facility Name

Galderma Investigational Site

City

Lublin

ZIP/Postal Code

20-080

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

02-625

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Galderma Investigational Site

City

Wrocław

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Galderma Investigational Site

City

Łódź

ZIP/Postal Code

90-436

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

31449914

Citation

Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.

Results Reference

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Learn more about this trial

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

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Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial