NCT03921411

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

Completed Phase 2 Results posted Last updated 21 April 2023

What this trial tests

Phase 2 trial testing Nemolizumab in Atopic Dermatitis in 20 participants. Completed in 19 August 2020.

Timeline

9 April 2019

Primary endpoint
19 August 2020

19 August 2020

Quick facts

Lead sponsor	Galderma R&D
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	9 April 2019
Primary completion	19 August 2020
Estimated completion	19 August 2020
Sites	10 locations across United States

Drugs / interventions tested

• Nemolizumab (NEMOLIZUMAB) — full drug profile →

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 12 to 17, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Nemolizumab Serum Concentrations at Week 1-2 Primary · At week 1-2

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	6478.8	± 2393.11

Nemolizumab Serum Concentrations at Week 4 Primary · At week 4

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	2935.3	± 1029.41

Nemolizumab Serum Concentrations at Week 8 Primary · At week 8

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	3292.3	± 2017.83

Nemolizumab Serum Concentrations at Week 12 Primary · At week 12

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	3221.6	± 1781.15

Nemolizumab Serum Concentrations at Week 16 Primary · At week 16

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	3010.0	± 1131.81

Nemolizumab Serum Concentrations at Week 24 Primary · At week 24

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Group	Value	95% CI
Nemolizumab	473.9	± 333.72

Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab Primary · 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 \[AUC (0-inf)\].

Group	Value	95% CI
Nemolizumab	0.325	± 0.153

Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab Primary · Baseline to week 24

Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).

Group	Value	95% CI
Nemolizumab	7.15	± 2.24

Population Lag Time (Tlag) Primary · 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.

Group	Value	95% CI
Nemolizumab	1.0728	± 0

First Order Constant of Absorption (ka) Primary · 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.

Group	Value	95% CI
Nemolizumab	0.402	± 0.145

Maximum Observed Serum Concentration (Cmax) of Nemolizumab Primary · Baseline to week 12

Cmax was obtained from serum concentration time curve.

Group	Value	95% CI
Nemolizumab	5975.5	± 2175.2

Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab Primary · Baseline to week 12

Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.

Group	Value	95% CI
Nemolizumab	5.862	± 1.669

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through Week 24. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nemolizumab

Serious: 2/18 (11%)

Deaths: 0/18

Serious adverse events (3 terms)

Reaction	System	Nemolizumab
Oedema peripheral	General disorders	—
Eczema infected	Infections and infestations	—
Staphylococcus skin infection	Infections and infestations	—

Other adverse events (10 terms — click to expand)

Reaction	System	Nemolizumab
Oedema peripheral	General disorders	—
Fatigue	General disorders	—
Bronchitis	Infections and infestations	—
Rash pustular	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Arthropod bite	Injury, poisoning and procedural complications	—
Blood creatine phosphokinase increased	Investigations	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Depression	Psychiatric disorders	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Oedema peripheral, Eczema infected, Staphylococcus skin infection.

Data from ClinicalTrials.gov NCT03921411 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biologics for Treatment of Atopic Dermatitis: Current Status and Future Prospect.
   Ratchataswan T, Banzon TM, Thyssen JP, Weidinger S, et al · · 2021 · cited 102× · PMID 33685604 · DOI 10.1016/j.jaip.2020.11.034
2. Current Insights into Immunology and Novel Therapeutics of Atopic Dermatitis.
   Kader HA, Azeem M, Jwayed SA, Al-Shehhi A, et al · · 2021 · cited 61× · PMID 34200009 · DOI 10.3390/cells10061392
3. A New Generation of Treatments for Itch.
   Fowler E, Yosipovitch G. · · 2020 · cited 30× · PMID 31940047 · DOI 10.2340/00015555-3347
4. Blockage of the IL-31 Pathway as a Potential Target Therapy for Atopic Dermatitis.
   Orfali RL, Aoki V. · · 2023 · cited 29× · PMID 36839897 · DOI 10.3390/pharmaceutics15020577
5. Unraveling Atopic Dermatitis: Insights into Pathophysiology, Therapeutic Advances, and Future Perspectives.
   Pareek A, Kumari L, Pareek A, Chaudhary S, et al · · 2024 · cited 27× · PMID 38474389 · DOI 10.3390/cells13050425
6. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents.
   Sidbury R, Alpizar S, Laquer V, Dhawan S, et al · · 2022 · cited 27× · PMID 35088348 · DOI 10.1007/s13555-021-00678-7
7. Emerging Biologic Therapies for the Treatment of Atopic Dermatitis.
   Alvarenga JM, Bieber T, Torres T. · · 2024 · cited 20× · PMID 39365406 · DOI 10.1007/s40265-024-02095-4
8. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
   Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700