A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03921411
• Collaborator: (none)
• Enrollment: 20
• Locations: 10
• Arm: 1
• Actual Duration (Months): 16.4
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Biological: Nemolizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis
• Actual Study Start Date: Apr 9, 2019
• Actual Primary Completion Date: Aug 19, 2020
• Actual Study Completion Date: Aug 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemolizumab Nemolizumab	Biological: Nemolizumab; Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.

Outcome Measures

Primary Outcome Measures

1. Nemolizumab serum concentration in adolescent subjects [Baseline to Week 24]

2. Incidence of adverse events, including TEAEs, AESIs and SAEs [Baseline to Week 24]

3. Number of subjects who have a change from baseline in physical examinations (normal to abnormal) at each visit [Baseline to Week 24]

   A complete physical exam includes: Head, ears, eyes, nose, throat, neck (including thyroid) Skin/integumentary system Cardiovascular system Respiratory system Gastrointestinal system Musculoskeletal system Lymph nodes Nervous system Respiratory exam

4. Number of subjects who have a change from baseline in vital signs (normal to abnormal) at each visit [Baseline to Week 24]

   Vital signs includes: Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Temperature

5. Number of subjects who have clinically significant laboratory abnormalities in hematology, blood chemistry, or urinalysis results at each visit [Baseline to Week 24]

6. Number of subjects who have a clinically significant abnormal ECG [Screening to Week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria

• Male or female participants ≥ 12 to < 17 years of age

• Chronic AD that has been documented for at least 2 years

• Eczema Area and Severity Index (EASI) score ≥ 16

• Investigator's Global Assessment (IGA) score ≥ 3

• AD involvement ≥ 10% of Body Surface Area (BSA)

• Documented recent history of inadequate response to topical medications

• Women of childbearing potential must agree to be strictly abstinent 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

• Body weight < 30 kilogram (kg)

• Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)

• Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational Site	Fountain Valley	California	United States	92708
2	Galderma Investigational Site	Fremont	California	United States	94538
3	Galderma Investigational Site	Jacksonville	Florida	United States	32256
4	Galderma Investigational Site	Tampa	Florida	United States	33607
5	Galderma Investigational Site	Columbus	Georgia	United States	31904
6	Galderma Investigational Site	Sandy Springs	Georgia	United States	30128
7	Galderma Investigational Site	Gresham	Oregon	United States	97030
8	Galderma Investigational Site	Dallas	Texas	United States	75230-5806
9	Galderma Investigational Site	Frisco	Texas	United States	75034
10	Galderma Investigational Site	Richmond	Virginia	United States	23220

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT03921411
• Other Study ID Numbers: RD.06.SPR.116912
• First Posted: Apr 19, 2019
• Last Update Posted: Aug 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Aug 24, 2021