Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT NCT04501679)

Last Updated: 2024-07-10

Results Overview

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

274 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2024-07-10

Participant Flow

The study was conducted at 55 sites in 9 countries.

A total of 274 participants were randomized and treated (183 participants in Nemolizumab and 91 participants in Placebo group) received treatment in this study.

Participant milestones

Participant milestones
Measure	Nemolizumab Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Overall Study STARTED	183	91
Overall Study Treated	183	91
Overall Study COMPLETED	174	88
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Nemolizumab Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Overall Study Pregnancy	0	1
Overall Study Adverse Event	4	2
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.	Total n=274 Participants Total of all reporting groups
Age, Continuous	53.7 Years STANDARD_DEVIATION 14.41 • n=5 Participants	50.8 Years STANDARD_DEVIATION 15.00 • n=7 Participants	52.7 Years STANDARD_DEVIATION 14.64 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	55 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	36 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	173 Participants n=5 Participants	79 Participants n=7 Participants	252 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White	147 Participants n=5 Participants	68 Participants n=7 Participants	215 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Others	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Europe	122 Participants n=5 Participants	61 Participants n=7 Participants	183 Participants n=5 Participants
Region of Enrollment North America	47 Participants n=5 Participants	22 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment Pacifica	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population consisted of all randomized participants.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16	103 Participants	19 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population consisted of all randomized participants.

IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16	69 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT population consisted of all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4	75 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 16

Population: ITT population consisted all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With PP NRS < 2 at Week 16	64 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population consisted all randomized participants.

The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16	95 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT population consisted of all randomized participants.

The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4	68 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 4

Population: ITT population consisted all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With PP NRS < 2 at Week 4	36 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline up to end of treatment period (16 Weeks)

Population: Safety population included all randomized participants who received at least 1 administration of study drug.

AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.

Outcome measures

Outcome measures
Measure	Nemolizumab n=183 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) Treatment Emergent Adverse Events (TEAEs)	112 Participants	48 Participants
Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) Adverse Events of Special Interest (AESIs)	21 Participants	9 Participants
Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) Serious Adverse Events (SAEs)	4 Participants	5 Participants

Adverse Events

Nemolizumab

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nemolizumab n=183 participants at risk Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 participants at risk Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Cardiac disorders Supraventricular tachycardia	0.55% 1/183 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Cardiac disorders Atrial flutter	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Cardiac disorders Coronary artery occlusion	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Cardiac disorders Myocardial infarction	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Infections and infestations Pneumococcal sepsis	0.55% 1/183 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Infections and infestations Pneumonia	0.55% 1/183 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Infections and infestations Appendicitis	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Infections and infestations Postoperative wound infection	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Skin and subcutaneous tissue disorders Dermatitis contact	0.55% 1/183 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Skin and subcutaneous tissue disorders Pemphigoid	0.55% 1/183 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/183 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	1.1% 1/91 • Number of events 1 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.

Other adverse events

Other adverse events
Measure	Nemolizumab n=183 participants at risk Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=91 participants at risk Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Nervous system disorders Headache	6.6% 12/183 • Number of events 17 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	4.4% 4/91 • Number of events 4 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.5% 10/183 • Number of events 15 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	0.00% 0/91 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
Skin and subcutaneous tissue disorders Neurodermatitis	3.8% 7/183 • Number of events 7 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.	11.0% 10/91 • Number of events 10 • From baseline up to end of treatment period (16 Weeks) Safety population included all randomized participants who received at least 1 administration of study drug. TEAEs during Treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER