Trial · NCT03921411

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

NCT03921411, Phase 2, Completed, Galderma R&D; results first posted 2023-04-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD). Trials, record NCT03921411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03921411

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
NCT number: NCT03921411
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Galderma R&D
Conditions: Atopic Dermatitis
Interventions: Nemolizumab
First posted: 2019-04-19
Last updated: 2023-04-21
Results first posted: 2023-04-21

Source ClinicalTrials.gov

Registered outcomes52

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Nemolizumab Serum Concentrations at Week 1-2	At week 1-2	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Nemolizumab Serum Concentrations at Week 4	At week 4	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Nemolizumab Serum Concentrations at Week 8	At week 8	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Nemolizumab Serum Concentrations at Week 12	At week 12	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Nemolizumab Serum Concentrations at Week 16	At week 16	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Nemolizumab Serum Concentrations at Week 24	At week 24	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Primary	Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab	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 \[AUC (0-inf)\].
Primary	Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab	Baseline to week 24	Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).
Primary	Population Lag Time (Tlag)	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.
Primary	First Order Constant of Absorption (ka)	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.

1 to 10 of 52Source ClinicalTrials.gov

See all 52 registered outcomes

Outcomes52

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Nemolizumab Serum Concentrations at Week 1-2	At week 1-2	The pharmacokinetic (PK) population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	nanogram per milliliter (ng/mL)	MEAN
PRIMARY	Nemolizumab Serum Concentrations at Week 4	At week 4	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	MEAN
PRIMARY	Nemolizumab Serum Concentrations at Week 8	At week 8	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	MEAN
PRIMARY	Nemolizumab Serum Concentrations at Week 12	At week 12	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	MEAN
PRIMARY	Nemolizumab Serum Concentrations at Week 16	At week 16	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	MEAN
PRIMARY	Nemolizumab Serum Concentrations at Week 24	At week 24	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	ng/mL	MEAN
PRIMARY	Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab	Baseline to week 24	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.	liter/day (L/day)	MEAN
PRIMARY	Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab	Baseline to week 24	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	liter	MEAN
PRIMARY	Population Lag Time (Tlag)	Baseline to week 24	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	hours	MEAN
PRIMARY	First Order Constant of Absorption (ka)	Baseline to week 24	PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value	1/day	MEAN

1 to 10 of 52Source ClinicalTrials.gov

See all 52 outcomes

Results by group68

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Nemolizumab Serum Concentrations at Week 1-2	Nemolizumab	6478.8	Standard Deviation 2393.11	nanogram per milliliter (ng/mL)
Nemolizumab Serum Concentrations at Week 4	Nemolizumab	2935.3	Standard Deviation 1029.41	ng/mL
Nemolizumab Serum Concentrations at Week 8	Nemolizumab	3292.3	Standard Deviation 2017.83	ng/mL
Nemolizumab Serum Concentrations at Week 12	Nemolizumab	3221.6	Standard Deviation 1781.15	ng/mL
Nemolizumab Serum Concentrations at Week 16	Nemolizumab	3010.0	Standard Deviation 1131.81	ng/mL
Nemolizumab Serum Concentrations at Week 24	Nemolizumab	473.9	Standard Deviation 333.72	ng/mL
Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab	Nemolizumab	0.325	Standard Deviation 0.153	liter/day (L/day)
Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab	Nemolizumab	7.15	Standard Deviation 2.24	liter
Population Lag Time (Tlag)	Nemolizumab	1.0728	Standard Deviation 0	hours
First Order Constant of Absorption (ka)	Nemolizumab	0.402	Standard Deviation 0.145	1/day

1 to 10 of 68Source ClinicalTrials.gov

See all 68 results by group

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nemolizumab	20
Overall Study	Treated	Nemolizumab	18
Overall Study	COMPLETED	Nemolizumab	15
Overall Study	NOT COMPLETED	Nemolizumab	5

Source ClinicalTrials.gov

Adverse events13

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Oedema peripheral	General disorders	Nemolizumab	1	18
other	Fatigue	General disorders	Nemolizumab	1	18
other	Bronchitis	Infections and infestations	Nemolizumab	1	18
other	Rash pustular	Infections and infestations	Nemolizumab	1	18
other	Upper respiratory tract infection	Infections and infestations	Nemolizumab	1	18
other	Arthropod bite	Injury, poisoning and procedural complications	Nemolizumab	1	18
other	Blood creatine phosphokinase increased	Investigations	Nemolizumab	1	18
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Nemolizumab	1	18
other	Depression	Psychiatric disorders	Nemolizumab	1	18
other	Dermatitis atopic	Skin and subcutaneous tissue disorders	Nemolizumab	1	18

1 to 10 of 13Source ClinicalTrials.gov

See all 13 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nemolizumab	0	18
Total, other adverse events	Nemolizumab	6	18
Total, serious adverse events	Nemolizumab	2	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35088348	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03921411

GET https://conductscience.org/api/trials/v1/NCT03921411/registered?page=2

API reference For AI assistants