Trial Outcomes & Findings for A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab (NCT NCT04365387)

Last Updated: 2025-06-05

Results Overview

Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (\>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations \>= 0.1 international unit per milliliter (IU/mL); or \>= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (\<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

242 participants

Primary outcome timeframe

At Week 16 (4 weeks post-vaccination)

Results posted on

2025-06-05

Participant Flow

The study was conducted at 42 sites in United states from 05 Mar 2020 to 07 Jul 2023.

A total of 242 participants were randomized and out of which only 234 received treatment in the study.

Participant milestones

Participant milestones
Measure	Nemolizumab Participants received a loading dose of nemolizumab (60 milligram \[mg\]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12.	Placebo Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12.
Overall Study STARTED	123	119
Overall Study Modified Intent to Treat (mITT) Population	80	78
Overall Study Safety Population	119	115
Overall Study COMPLETED	90	93
Overall Study NOT COMPLETED	33	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Nemolizumab Participants received a loading dose of nemolizumab (60 milligram \[mg\]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12.	Placebo Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12.
Overall Study Adverse Event	4	2
Overall Study Participants request	14	14
Overall Study Lost to Follow-up	8	5
Overall Study Protocol deviation	3	4
Overall Study Participant compliance with visit schedule	1	0
Overall Study Participant incarcerated	1	0
Overall Study Participant moved out of town (relocated)	0	1
Overall Study Participant PEF not eligible per sponsor	1	0
Overall Study Due to working hours, could not return to other visits	1	0

Baseline Characteristics

A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nemolizumab n=123 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=119 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Total n=242 Participants Total of all reporting groups
Age, Continuous	35.2 Years STANDARD_DEVIATION 11.62 • n=5 Participants	32.1 Years STANDARD_DEVIATION 12.00 • n=7 Participants	33.6 Years STANDARD_DEVIATION 11.89 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	69 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	50 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	73 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	62 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 16 (4 weeks post-vaccination)

Population: mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment.

Outcome measures

Outcome measures
Measure	Nemolizumab n=80 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=78 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)	67.5 Percentage of Participants	65.4 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 16 (4 weeks post-vaccination)

Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as \>= 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations \>= 0.1 IU/mL; or \>= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination Anti tetanus IgG concentrations \< 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.

Outcome measures

Outcome measures
Measure	Nemolizumab n=80 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=78 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)	78.8 Percentage of Participants	83.3 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 16

Percentage of participants with serum anti-tetanus IgG concentrations of \>= 0.1 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.

Outcome measures

Outcome measures
Measure	Nemolizumab n=80 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=78 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 16

Percentage of participants with serum anti-tetanus IgG concentrations of \>= 1.0 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.

Outcome measures

Outcome measures
Measure	Nemolizumab n=80 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=78 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16	97.5 Percentage of Participants	96.2 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 16

Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as \>= 4-fold increase in SBA reciprocal titer from baseline (using non-imputed values), at Week 16 (4 weeks postvaccination) were reported.

Outcome measures

Outcome measures
Measure	Nemolizumab n=61 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=66 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16	77.0 Percentage of Participants	63.6 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 16

Percentage of participants with a positive SBA response to MenC polysaccharide, defined as SBA reciprocal titer \>= 8, at Week 16 were reported. Immune response to meningococcal vaccination was determined by measuring functional antibody responses using an SBA assay.

Outcome measures

Outcome measures
Measure	Nemolizumab n=66 Participants Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=72 Participants Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16	83.3 Percentage of Participants	81.9 Percentage of Participants

Adverse Events

Nemolizumab

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nemolizumab n=119 participants at risk Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.	Placebo n=115 participants at risk Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/119 • From Day 1 up to end of study (Week 24) Safety Population included all randomized participants who received at least one administration of study drug.	0.87% 1/115 • From Day 1 up to end of study (Week 24) Safety Population included all randomized participants who received at least one administration of study drug.

Other adverse events

Additional Information

Sponsor

Galderma Research & Development, LLC

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place