North Little Rock, Arkansas 72117

  • Severe Atopic Dermatitis

Purpose:

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description


Study summary:

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD


Criteria:

Key Inclusion Criteria: 1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD 2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Key Exclusion Criteria: 1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject. 2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study. 3. Body weight < 30 kg 4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods. 5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) 6. Any clinically significant issue, based investigator judgement


Study is Available At:


Original ID:

RD.06.SPR.118163


NCT ID:

NCT03989206


Secondary ID:


Study Acronym:


Brief Title:

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis


Official Title:

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis


Overall Status:

Enrolling by invitation


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Galderma R&D


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

1700


Enrollment Type:

Anticipated


Study Dates

Start Date:December 30, 2019
Completion Date:August 31, 2026
Completion Type:Anticipated
Primary Completion Date:August 31, 2026
Primary Completion Type:Anticipated
Verification Date:August 2022
Last Changed Date:August 15, 2022
First Received Date:June 14, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence and Severity of TEAEs
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of Serious TEAEs
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of Participants with IGA score = 0-1 at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of Participants with EASI-75 at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Description:EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, tru
Outcome Type:Secondary Outcome
Measure:Proportion of Participants with IGA ≤ 2 at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change and Percent Change From Baseline in SCORAD Score at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in Dermatology Life Quality Index (DLQI)
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to First Relapse
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Remission
Time Frame:Baseline to Week 200
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Permanent Study Drug Discontinuation
Time Frame:Baseline to Week 200
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Nemolizumab
Description:Nemolizumab
Arm Name:Nemolizumab
Other Name:CD14152

Study Arms

Study Arm Type:Experimental
Arm Name:Nemolizumab
Description:Nemolizumab administered via subcutaneous injection

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Galderma R&D

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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