Atopic DermatitisPhase 2NCT03921411
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
A Phase 2 study testing Nemolizumab in people with Atopic Dermatitis, run by Galderma R&D at 10 sites in United States.
Trial summary
The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Apr 2019to 19 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Galderma Investigational Site
Columbus, Georgia, 31904
Galderma Investigational Site
Dallas, Texas, 75230-5806
Galderma Investigational Site
Fountain Valley, California, 92708
Galderma Investigational Site
Fremont, California, 94538
Galderma Investigational Site
Frisco, Texas, 75034
Galderma Investigational Site
Gresham, Oregon, 97030
Galderma Investigational Site
Jacksonville, Florida, 32256
Galderma Investigational Site
Richmond, Virginia, 23220
Galderma Investigational Site
Sandy Springs, Georgia, 30128
Galderma Investigational Site
Tampa, Florida, 33607
About this study
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
The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.
- Conditions
- Atopic Dermatitis
- Being tested
- Nemolizumab
- Keywords
- Nemolizumab, Atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemolizumabBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab | Experimental | Nemolizumab Receives: Biological: Nemolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nemolizumab Serum Concentrations at Week 1-2
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 1-2
Nemolizumab Serum Concentrations at Week 4
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 4
Nemolizumab Serum Concentrations at Week 8
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 8
Nemolizumab Serum Concentrations at Week 12
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 12
Nemolizumab Serum Concentrations at Week 16
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 16
Nemolizumab Serum Concentrations at Week 24
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Measured: At week 24
Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)].
Measured: Baseline to week 24
Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Measured: Baseline to week 24
Population Lag Time (Tlag)
Lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. The population Tlag value was estimated for the overall population and was reported in this endpoint.
Measured: Baseline to week 24
First Order Constant of Absorption (ka)
PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated.
Measured: Baseline to week 24
Maximum Observed Serum Concentration (Cmax) of Nemolizumab
Cmax was obtained from serum concentration time curve.
Measured: Baseline to week 12
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.
Measured: Baseline to week 12
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4
Ctrough is the concentration prior to study drug administration.
Measured: At week 4
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
Ctrough is the concentration prior to study drug administration.
Measured: At week 8
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
Ctrough is the concentration prior to study drug administration.
Measured: At week 12
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16
Ctrough is the concentration prior to study drug administration.
Measured: At week 16
Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)
Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 4 weeks post-dose
Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 8 weeks post-dose
Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 12 week post-dose
Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 16 weeks post-dose
Apparent Terminal Half-life (t1/2)
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the serum to decrease by 50%.
Measured: Baseline to week 24
Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4
Antidrug antibodies were determined using a validated enzyme-linked immunosorbent assay (ELISA) assay. Number of participants with positive ADA in Serum were reported.
Measured: At week 4
Number of Participants With Neutralizing Antibodies
The number of participants with neutralizing antibodies response at time of baseline up to week 24 has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay.
Measured: Baseline up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. An AESI is a noteworthy event for study drug that should be monitored closely and reported immediately. The following AEs will be considered AESIs: Anaphylactic reactions, Acute allergic reactions requiring treatment, Severe injection site reaction, Newly-diagnosed asthma or worsening of asthma, Peripheral edema: limbs, bilateral and Facial edema.
Measured: Baseline through week 24
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Measured: At week 1-2
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Measured: At week 4
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Measured: At week 8
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Measured: At week 12
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings
A complete PE included assessments of the head, ears, eyes, nose, throat, neck (including thyroid), skin/integumentary system, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. Clinical significance was determined by the investigator.
Measured: Baseline up to Week 24
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Laboratory investigation included hematology, biochemistry, and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant abnormalities in laboratory parameters were reported.
Measured: Baseline up to Week 24
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16
The ECG recordings were obtained after 10 minutes of rest in a semi-supine position. Number of participants with clinically significant change from baseline in ECG findings were reported. Clinically significance was decided by investigator.
Measured: At week 16
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included pulse rate, systolic and diastolic blood pressure (after the participant had been sitting for at least 5 minutes), and body temperature. Clinically significance was decided by investigator..
Measured: Baseline up to Week 24
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF <80% of predictive value is considered as abnormal.
Measured: At week 1-2
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF <80% of predictive value is considered as abnormal.
Measured: At week 4
Secondary outcomes (18)
Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 4 weeks post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 8 weeks post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule
Measured: Pre-dose through 12 week post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose through 16 weeks post-dose
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
EASI assesses severity and extent of atopic dermatitis (AD) signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The total EASI score range from 0 to 72 with higher scores representing greater severity of AD.
Measured: Baseline, Week 16
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The EASI score can range from 0 to 72 with higher scores representing greater severity of AD.
Measured: Baseline, Week 16
Number of Participants Who Achieved Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) From Baseline to Week 16
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. Ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), where higher score indicated higher severity. IGA success is defined as participants with 0 (clear) or 1 (almost clear) and at least 2 -grade improvement from baseline. Number of Participants who achieved Investigator's Global Assessment (IGA) Success from baseline to week 16 were reported.
Measured: Baseline to Week 16
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Measured: Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Measured: Baseline, Week 16
Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Measured: Baseline, Week 16
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Measured: Baseline, Week 16
Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Measured: Baseline, Week 16
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at 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 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.
Measured: Baseline, Week 16
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at 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 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.
Measured: Baseline, Week 16
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16
Scoring Atopic Dermatitis (SCORAD) is a validated measure commonly used to assess the severity and the extent of AD signs and symptoms. SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of six types of basic lesions (erythema/darkening, edema/papule, oozing/crusting, excoriation, lichenification/prurigo and dryness) and symptoms (itching and loss of sleep) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Measured: Baseline, Week 16
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Number of topical AD medication-free days through Week 16 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days.
Measured: Baseline through Week 24
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Measured: Baseline, Week 16
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start9 Apr 2019
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921411
- Sponsor's protocol ID
- RD.06.SPR.116912
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2019
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sidbury R, Alpizar S, Laquer V, Dhawan S, Abramovits W, Loprete L, Krishnaswamy JK, Ahmad F, Jabbar-Lopez Z, Piketty C. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Dermatol Ther (Heidelb). 2022 Mar;12(3):631-642. doi: 10.1007/s13555-021-00678-7. Epub 2022 Jan 28.
PubMed 35088348
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03921411
- Acronym / sponsor ID
- RD.06.SPR.116912
- Conditions
- Atopic Dermatitis
- Keywords
- Nemolizumab, Atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab | Experimental | Biological: NemolizumabNemolizumab |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NemolizumabParticipants 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. | Biological | Nemolizumab |
Primary outcome
Nemolizumab Serum Concentrations at Week 1-2
Time frame: At week 1-2
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 4
Time frame: At week 4
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 8
Time frame: At week 8
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 12
Time frame: At week 12
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 16
Time frame: At week 16
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Nemolizumab Serum Concentrations at Week 24
Time frame: At week 24
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab
Time frame: Baseline to week 24
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)].
Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab
Time frame: Baseline to week 24
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Population Lag Time (Tlag)
Time frame: Baseline to week 24
Lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. The population Tlag value was estimated for the overall population and was reported in this endpoint.
First Order Constant of Absorption (ka)
Time frame: Baseline to week 24
PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated.
Maximum Observed Serum Concentration (Cmax) of Nemolizumab
Time frame: Baseline to week 12
Cmax was obtained from serum concentration time curve.
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Time frame: Baseline to week 12
Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4
Time frame: At week 4
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
Time frame: At week 8
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
Time frame: At week 12
Ctrough is the concentration prior to study drug administration.
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16
Time frame: At week 16
Ctrough is the concentration prior to study drug administration.
Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)
Time frame: Pre-dose through 4 weeks post-dose
Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Time frame: Pre-dose through 8 weeks post-dose
Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Time frame: Pre-dose through 12 week post-dose
Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule.
Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Time frame: Pre-dose through 16 weeks post-dose
Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Apparent Terminal Half-life (t1/2)
Time frame: Baseline to week 24
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the serum to decrease by 50%.
Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4
Time frame: At week 4
Antidrug antibodies were determined using a validated enzyme-linked immunosorbent assay (ELISA) assay. Number of participants with positive ADA in Serum were reported.
Number of Participants With Neutralizing Antibodies
Time frame: Baseline up to Week 24
The number of participants with neutralizing antibodies response at time of baseline up to week 24 has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
Time frame: Baseline through week 24
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. An AESI is a noteworthy event for study drug that should be monitored closely and reported immediately. The following AEs will be considered AESIs: Anaphylactic reactions, Acute allergic reactions requiring treatment, Severe injection site reaction, Newly-diagnosed asthma or worsening of asthma, Peripheral edema: limbs, bilateral and Facial edema.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2
Time frame: At week 1-2
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4
Time frame: At week 4
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8
Time frame: At week 8
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12
Time frame: At week 12
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings
Time frame: Baseline up to Week 24
A complete PE included assessments of the head, ears, eyes, nose, throat, neck (including thyroid), skin/integumentary system, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Time frame: Baseline up to Week 24
Laboratory investigation included hematology, biochemistry, and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant abnormalities in laboratory parameters were reported.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16
Time frame: At week 16
The ECG recordings were obtained after 10 minutes of rest in a semi-supine position. Number of participants with clinically significant change from baseline in ECG findings were reported. Clinically significance was decided by investigator.
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Baseline up to Week 24
Vital signs included pulse rate, systolic and diastolic blood pressure (after the participant had been sitting for at least 5 minutes), and body temperature. Clinically significance was decided by investigator..
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2
Time frame: At week 1-2
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF <80% of predictive value is considered as abnormal.
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4
Time frame: At week 4
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF <80% of predictive value is considered as abnormal.
18 secondary outcomes
Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
Time frame: Pre-dose through 4 weeks post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
Time frame: Pre-dose through 8 weeks post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
Time frame: Pre-dose through 12 week post-dose
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
Time frame: Pre-dose through 16 weeks post-dose
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Time frame: Baseline, Week 16
Number of Participants Who Achieved Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) From Baseline to Week 16
Time frame: Baseline to Week 16
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Time frame: Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16
Time frame: Baseline, Week 16
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Time frame: Baseline through Week 24
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
Time frame: Baseline, Week 16
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35088348Sidbury R, Alpizar S, Laquer V, Dhawan S, Abramovits W, Loprete L, Krishnaswamy JK, Ahmad F, Jabbar-Lopez Z, Piketty C. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Dermatol Ther (Heidelb). 2022 Mar;12(3):631-642. doi: 10.1007/s13555-021-00678-7. Epub 2022 Jan 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nemolizumab in people with Atopic Dermatitis, run by Galderma R&D at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nemolizumab Serum Concentrations at Week 1-2 (time frame: At week 1-2). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.