Trial Outcomes & Findings for A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis (NCT NCT05052983)

Last Updated: 2024-10-08

Results Overview

Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Baseline up to Week 24

Results posted on

2024-10-08

Participant Flow

This study was conducted at 14 study sites in 7 countries from 24 January 2022 to 11 September 2023.

A total of 34 participants from long-term extension (LTE) study RD.06.SPR.202699 (NCT05052983) were enrolled and treated in this study.

Participant milestones

Participant milestones
Measure	Nemolizumab Participants received either 1 (30 milligram \[mg\]) or 2 (2\*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by interactive response technology (IRT).	Placebo Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Overall Study STARTED	18	16
Overall Study COMPLETED	14	4
Overall Study NOT COMPLETED	4	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Nemolizumab Participants received either 1 (30 milligram \[mg\]) or 2 (2\*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by interactive response technology (IRT).	Placebo Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Overall Study Lack of Efficacy	3	12
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nemolizumab n=18 Participants Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Placebo n=16 Participants Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Total n=34 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 14.06 • n=5 Participants	59.1 years STANDARD_DEVIATION 13.41 • n=7 Participants	59.5 years STANDARD_DEVIATION 13.56 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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: Baseline up to Week 24

Population: ITT population included all randomized participants. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Nemolizumab n=3 Participants Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Placebo n=12 Participants Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria	NA Days Median, lower and upper limits of 95 percent (%) confidence interval (CI) could not be estimated due to insufficient data for time to relapse, as number of participants with relapse are only 3.	112.50 Days Interval 84.0 to 161.0

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: ITT population included all randomized participants. Here, number analyzed signifies participants who were evaluable for given categories. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data.

IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear).

Outcome measures

Outcome measures
Measure	Nemolizumab n=18 Participants Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Placebo n=16 Participants Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 8	82.4 Percentage of Participants	81.3 Percentage of Participants
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 12	88.2 Percentage of Participants	53.3 Percentage of Participants
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 24	85.7 Percentage of Participants	60.0 Percentage of Participants
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 4	88.2 Percentage of Participants	86.7 Percentage of Participants
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 16	81.3 Percentage of Participants	27.3 Percentage of Participants
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit At Week 20	86.7 Percentage of Participants	57.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Pruritus NRS is a scale that is used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Nemolizumab n=18 Participants Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Placebo n=16 Participants Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 4	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 8	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 12	0 Percentage of Participants	16.7 Percentage of Participants
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 16	6.7 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 20	0 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit At Week 24	0 Percentage of Participants	0 Percentage of Participants

Adverse Events

Nemolizumab

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nemolizumab n=18 participants at risk Participants received either 1(30mg) or 2(2\*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.	Placebo n=16 participants at risk Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (NCT05052983), as assigned by IRT.
Injury, poisoning and procedural complications Clavicle fracture	5.6% 1/18 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.	0.00% 0/16 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Concussion	5.6% 1/18 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.	0.00% 0/16 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.
Nervous system disorders Cerebral ischaemia	5.6% 1/18 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.	0.00% 0/16 • From Baseline up to end of study (Week 32) The safety population included all randomized participants who receive at least 1 dose of study drug.

Other adverse events

Additional Information

Sponsor

Galderma Research & Development

Phone: (817) 961-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place