Dose-ranging Study of Nemolizumab in Atopic Dermatitis

NCT03100344 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RD.03.SPR.114322
• Study Type: interventional
• Target: 226
• Locations: 6 countries
• Sites: 67

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Week 24

Secondary Outcomes (17)

• 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

• 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

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

Study Arms (4)

Group 1

EXPERIMENTAL

Nemolizumab (low dose)

Drug: Nemolizumab

Group 2

EXPERIMENTAL

Nemolizumab (medium dose)

Drug: Nemolizumab

Group 3

EXPERIMENTAL

Nemolizumab (high dose)

Drug: Nemolizumab

Group 4

PLACEBO COMPARATOR

Nemolizumab placebo

Drug: Placebo

Interventions

Nemolizumab DRUG

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

Group 1; Group 2; Group 3

Placebo DRUG

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

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (67)

Galderma Investigational site

Birmingham, Alabama, 35209, United States

Location

Galderma Investigational site

Fort Smith, Arkansas, 72916, United States

Location

Galderma Investigational site

Beverly Hills, California, 90212, United States

Location

Galderma Investigational site

Fountain Valley, California, 92708, United States

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Galderma Investigational site

Fremont, California, 94538, United States

Location

Galderma Investigational site

Rolling Hills Estates, California, 90274, United States

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Galderma Investigational site

Santa Ana, California, 92701, United States

Location

Galderma Investigational site

Santa Monica, California, 90404, United States

Location

Galderma Investigational site

Miami, Florida, 33135, United States

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Galderma Investigational site

Tampa, Florida, 33607, United States

Location

Galderma Investigational Site

Tampa, Florida, 33624, United States

Location

Galderma Investigational site

Columbus, Georgia, 31904, United States

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Galderma Investigational site

Sandy Springs, Georgia, 30328, United States

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Galderma Investigational Site

Darien, Illinois, 60561, United States

Location

Galderma Investigational Site

Overland Park, Kansas, 66215, United States

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Galderma Investigational site

New Orleans, Louisiana, 70115, United States

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Galderma Investigational Site

Farmington Hills, Michigan, 78334, United States

Location

Galderma Investigational site

Forest Hills, New York, 11375, United States

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Galderma Investigational site

New York, New York, 10025, United States

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Galderma Investigational Site

New York, New York, 10075, United States

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Galderma Investigational site

Chapel Hill, North Carolina, 27516, United States

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Galderma Investigational Site

Johnston, Rhode Island, 02919, United States

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Galderma Investigational site

Dallas, Texas, 75230, United States

Location

Galderma Investigational site

San Antonio, Texas, 78218, United States

Location

Galderma Investigational Site

Waco, Texas, 76710, United States

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Galderma Investigational site

Richmond, Virginia, 23220, United States

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Galderma Investigational Site

Benowa, 4217 QLD, Australia

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Galderma Investigational Site

Kogarah, NSW 2217, Australia

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Galderma Investigational Site

Melbourne, VIC3002, Australia

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Galderma Investigational Site

Phillip, ACT2606, Australia

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Galderma Investigational Site

Calgary, AB T3A 2N1, Canada

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Galderma Investigational Site

Markham, ON L3P 1X2, Canada

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Galderma Investigational Site

Oakville, ON L6J 7W5, Canada

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Galderma Investigational Site

Ottawa, K1G 6C6, Canada

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Galderma Investigational Site

Ottawa, ON K2G 6E2, Canada

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Galderma Investigational Site

Peterborough, K9J, Canada

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Galderma Investigational Site

Richmond Hill, ON L4C, Canada

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Galderma Investigational Site

Sainte-Foy, QC G1V4X7, Canada

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Galderma Investigational Site

Waterloo, ON N2J 1C4, Canada

Location

Galderma Investigational Site

Bordeaux, 33075, France

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Galderma Investigational Site

Lille, 59037, France

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Galderma Investigational Site

Marseille, 13385, France

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Galderma Investigational Site

Nice, 06202, France

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Galderma Investigational Site

Paris, 75010, France

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Galderma Investigational Site

Toulouse, 31059, France

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Galderma Investigational Site

Berlin, 10117, Germany

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Galderma Investigational Site

Berlin, 10789, Germany

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Galderma Investigational Site

Darmstadt, 64283, Germany

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Galderma Investigational Site

Erlangen, 91054, Germany

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Galderma Investigational Site

Frankfurt, 60590, Germany

Location

Galderma Investigational Site

Hamburg, 20354, Germany

Location

Galderma Investigational Site

Hannover, 30625, Germany

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Galderma Investigational Site

Heidelberg, 69120, Germany

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Galderma Investigational Site

Langenau, 89129, Germany

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Galderma Investigational Site

Mainz, 55131, Germany

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Galderma Investigational Site

München, 80337, Germany

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Galderma Investigational Site

Osnabrück, 49074, Germany

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Galderma Investigational Site

Stuttgart, 70718, Germany

Location

Galderma Investigational Site

Katowice, 40-123, Poland

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Galderma Investigational Site

Katowice, 40-648, Poland

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Galderma Investigational Site

Krakow, 31-024, Poland

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Galderma Investigational Site

Lodz, 90-436, Poland

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Galderma Investigational Site

Lublin, 20-080, Poland

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Galderma Investigational Site

Warsaw, 01-817, Poland

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Galderma Investigational Site

Warsaw, 02-625, Poland

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Galderma Investigational Site

Warsaw, 02-758, Poland

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Galderma Investigational Site

Wroclaw, 51-318, Poland

Location

Related Publications (1)

• 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.

  PMID: 31449914 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Kenny Frazier
• Organization: Galderma

Kenny.frazier@galderma.com

817-961-5120

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: June 14, 2017
• Primary Completion: July 19, 2018
• Study Completion: September 21, 2018
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-10

Locations

CA (9); FR (6); DE (13); US (26); AU (4); PL (9)