Trial Outcomes & Findings for Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus (NCT NCT05885737)

Last Updated: 2025-09-12

Results Overview

On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a numerical rating scale (NRS) scale from 0 to 10, where 0 represents "no itching" and 10 was "worst itching imaginable". A higher score indicated a more severe outcome. The weekly mean of the daily values of the daily 24-hour WI-NRS was calculated for the analysis. The least square (LS) means of change from baseline to Week 4 in the weekly mean of the daily 24-hour WI-NRS score was estimated using the mixed model repeated measures (MMRM) method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline WI-NRS score as fixed continuous effects.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

260 participants

Primary outcome timeframe

From Baseline to Week 4

Results posted on

2025-09-12

Participant Flow

This study was conducted at 35 investigative sites in China.

A total of 291 participants were screened, and 31 of these were screen failures. Of the screened participants, 260 were randomized in the study. Of these 260 participants, 227 completed the double blind (DB) treatment period and 217 of these participants entered the open-label extension (OLE) period of the study.

Participant milestones

Participant milestones
Measure	Difelikefalin/Difelikefalin Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	Placebo/Difelikefalin Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
DB Period STARTED	130	130
DB Period Treated	129	130
DB Period COMPLETED	110	117
DB Period NOT COMPLETED	20	13
OLE Period STARTED	103	114
OLE Period Treated	103	113
OLE Period COMPLETED	92	106
OLE Period NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Difelikefalin/Difelikefalin Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	Placebo/Difelikefalin Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
DB Period Adverse Event	4	4
DB Period Lost to Follow-up	0	1
DB Period Physician Decision	2	0
DB Period Withdrawal by Subject	12	6
DB Period Other: Unspecified	2	2
OLE Period Adverse Event	3	2
OLE Period Physician Decision	1	0
OLE Period Withdrawal by Subject	5	5
OLE Period Other: Unspecified	2	1

Baseline Characteristics

Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	Total n=259 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 12.26 • n=93 Participants	55.7 years STANDARD_DEVIATION 12.38 • n=4 Participants	56.0 years STANDARD_DEVIATION 12.30 • n=27 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	42 Participants n=4 Participants	86 Participants n=27 Participants
Sex: Female, Male Male	85 Participants n=93 Participants	88 Participants n=4 Participants	173 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Chinese	129 Participants n=93 Participants	130 Participants n=4 Participants	259 Participants n=27 Participants
WI-NRS	7.35 score on a scale STANDARD_DEVIATION 1.291 • n=93 Participants	7.00 score on a scale STANDARD_DEVIATION 1.223 • n=4 Participants	7.18 score on a scale STANDARD_DEVIATION 1.268 • n=27 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 4

Population: Analysis was performed on the FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=119 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=126 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period	-2.09 score on a scale Standard Error 0.198	-1.27 score on a scale Standard Error 0.194	—	—

SECONDARY outcome

Timeframe: From Baseline, and at Weeks 4, 8, and 12

Population: Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint.

On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a NRS scale from 0 to 10, where 0 represents "no itching" and 10 was "worst itching imaginable". A higher score indicated a more severe outcome. The weekly mean of the daily values of the daily 24-hour WI-NRS was calculated for the analysis. Missing weekly mean WI-NRS data were imputed using missing at random (MAR) multiple imputation (MI) approach, assuming that participants who do not have weekly mean WI-NRS score at a timepoint would have similar weekly mean WI-NRS scores as other participants in their respective treatment arm who have complete data. The percentage of participants were estimated using a logistic regression model with terms for treatment group, baseline WI-NRS score, use of anti-itch medication during the week prior to randomisation, and the presence of specific medical conditions at baseline.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Percentage of Participants Achieving Greater Than or Equal to (>=) 3-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 4	21.9 percentage of participants Interval 11.4 to 38.1	8.9 percentage of participants Interval 3.9 to 19.0	—	—
Percentage of Participants Achieving Greater Than or Equal to (>=) 3-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 8	35.8 percentage of participants Interval 22.7 to 51.3	22.3 percentage of participants Interval 12.9 to 35.8	—	—
Percentage of Participants Achieving Greater Than or Equal to (>=) 3-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 12	48.7 percentage of participants Interval 34.2 to 63.3	33.8 percentage of participants Interval 22.0 to 48.0	—	—

SECONDARY outcome

Timeframe: From Baseline, and at Weeks 4, 8, and 12

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Percentage of Participants Achieving at Least 4-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 4	10.9 percentage of participants Interval 3.7 to 28.1	2.2 percentage of participants Interval 0.5 to 8.8	—	—
Percentage of Participants Achieving at Least 4-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 8	21.2 percentage of participants Interval 11.2 to 36.6	11.6 percentage of participants Interval 5.4 to 23.2	—	—
Percentage of Participants Achieving at Least 4-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period Week 12	29.9 percentage of participants Interval 18.1 to 45.3	19.7 percentage of participants Interval 10.9 to 32.9	—	—

SECONDARY outcome

Timeframe: From Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a NRS scale from 0 to 10, where 0 represents "no itching" and 10 was "worst itching imaginable". A higher score indicated a more severe outcome. The weekly mean of the daily values was calculated for the analysis. The weekly mean of the daily values of the daily 24-hour WI-NRS was calculated for the analysis. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline WI-NRS score as fixed continuous effects.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 1	-0.68 score on a scale Standard Error 0.153	-0.53 score on a scale Standard Error 0.149	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 2	-1.37 score on a scale Standard Error 0.179	-0.89 score on a scale Standard Error 0.175	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 3	-1.86 score on a scale Standard Error 0.188	-1.08 score on a scale Standard Error 0.185	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 4	-2.09 score on a scale Standard Error 0.198	-1.27 score on a scale Standard Error 0.194	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 5	-2.35 score on a scale Standard Error 0.208	-1.46 score on a scale Standard Error 0.204	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 6	-2.51 score on a scale Standard Error 0.216	-1.55 score on a scale Standard Error 0.212	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 7	-2.61 score on a scale Standard Error 0.219	-1.78 score on a scale Standard Error 0.215	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 8	-2.71 score on a scale Standard Error 0.222	-1.96 score on a scale Standard Error 0.217	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 9	-2.90 score on a scale Standard Error 0.223	-2.00 score on a scale Standard Error 0.218	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 10	-2.97 score on a scale Standard Error 0.227	-2.04 score on a scale Standard Error 0.222	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 11	-3.08 score on a scale Standard Error 0.228	-2.16 score on a scale Standard Error 0.223	—	—
Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period Week 12	-3.11 score on a scale Standard Error 0.235	-2.16 score on a scale Standard Error 0.229	—	—

SECONDARY outcome

Timeframe: From Baseline to Weeks 4, 8, and 12

The 5-D itch scale is a questionnaire where participants assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution). The scores of each of the 5 domains are achieved separately and then summed together to obtain a total 5-D score. 5-D itch scale scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus) where a higher score indicates a more severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the 5-D itch scale total score was estimated using the MMRM method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment sequence, visit, and treatment sequence-by-visit-interaction as fixed categorical effects and baseline 5-D Itch score (total score) as fixed continuous effects.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period) Week 4	-3.3 score on a scale Standard Error 0.37	-2.5 score on a scale Standard Error 0.36	—	—
Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period) Week 8	-3.9 score on a scale Standard Error 0.38	-2.8 score on a scale Standard Error 0.37	—	—
Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period) Week 12	-4.3 score on a scale Standard Error 0.40	-3.6 score on a scale Standard Error 0.39	—	—

SECONDARY outcome

Timeframe: From Baseline to OLE Period - Weeks 4, 8, 12, and 14

Population: Analysis was performed on the OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=103 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=113 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) Week 4	-5.0 score on a scale Standard Error 0.40	-5.3 score on a scale Standard Error 0.38	—	—
Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) Week 8	-5.4 score on a scale Standard Error 0.40	-5.8 score on a scale Standard Error 0.37	—	—
Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) Week 12	-5.7 score on a scale Standard Error 0.41	-6.0 score on a scale Standard Error 0.39	—	—
Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) Week 14	-6.2 score on a scale Standard Error 0.41	-6.0 score on a scale Standard Error 0.38	—	—

SECONDARY outcome

Timeframe: From Baseline to Weeks 4, 8, and 12

The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity. Participants are asked the question "During the past week, how often have you been bothered by" and respond by filling in 1 of 7 circles numbered from 0 (labelled with the anchor phrase "never bothered") to 6 (labelled as "always bothered") for each of the 10 questions. The total score is the sum of the numeric value of each answered question. Here, a higher score indicated a severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the Skindex-10 scale total score was estimated using the MMRM method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline skindex-10 scale score (total score) as fixed continuous effects.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) Week 4	-9.1 score on a scale Standard Error 1.46	-5.1 score on a scale Standard Error 1.43	—	—
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) Week 8	-11.3 score on a scale Standard Error 1.51	-7.4 score on a scale Standard Error 1.48	—	—
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) Week 12	-10.5 score on a scale Standard Error 1.59	-9.5 score on a scale Standard Error 1.55	—	—

SECONDARY outcome

Timeframe: From Baseline to OLE Period - Weeks 4, 8, 12, and 14

Population: For the OLE period analysis was performed on OLE-SAS, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=103 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=113 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) Week 4	-14.7 score on a scale Standard Error 1.47	-14.1 score on a scale Standard Error 1.39	—	—
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) Week 8	-15.8 score on a scale Standard Error 1.49	-15.2 score on a scale Standard Error 1.41	—	—
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) Week 12	-17.5 score on a scale Standard Error 1.48	-16.4 score on a scale Standard Error 1.39	—	—
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) Week 14	-18.3 score on a scale Standard Error 1.56	-15.8 score on a scale Standard Error 1.48	—	—

SECONDARY outcome

Timeframe: At Week 12

Population: Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for the outcome measure.

The Patient Global Impression of Change is a global participant reported outcome measure that assesses the change in itch (no change, improvement or worsening) overall relative to the start of the study. The scale has only 1 item, and the participant was asked to mark the category that best describes the change in itch ranging from "Very Much Improved" to "Very Much Worse". Number of participants within all individual categories are reported here.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=110 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=119 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Patient Global Impression of Change Minimally improved	22 Participants	49 Participants	—	—
Patient Global Impression of Change No change	18 Participants	24 Participants	—	—
Patient Global Impression of Change Minimally worse	2 Participants	2 Participants	—	—
Patient Global Impression of Change Much worse	2 Participants	1 Participants	—	—
Patient Global Impression of Change Very Much worse	0 Participants	0 Participants	—	—
Patient Global Impression of Change Very much improved	20 Participants	14 Participants	—	—
Patient Global Impression of Change Much improved	46 Participants	29 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)

Population: Analysis was performed on safety analysis set in DB period (DB-SAF). DB-SAF included all randomized participants who received at least 1 dose of investigational product during the DB period. For the OLE period analysis was performed on OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin n=103 Participants Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin n=113 Participants Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Number of Participants With Adverse Events (AEs)	106 Participants	92 Participants	82 Participants	90 Participants

SECONDARY outcome

Timeframe: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)

Population: The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint.

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) DB period: Week 12	41 Participants	48 Participants	—	—
Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) OLE period: Week 14	34 Participants	46 Participants	—	—

SECONDARY outcome

Timeframe: From baseline to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)

Outcome measures

Outcome measures
Measure	DB Period: Difelikefalin n=129 Participants Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 Participants Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin Upon completion of the DB period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin Upon completion of the DB period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations	0 Participants	0 Participants	—	—

Adverse Events

DB Period: Difelikefalin

Serious events: 18 serious events

Other events: 85 other events

Deaths: 0 deaths

DB Period: Placebo

Serious events: 12 serious events

Other events: 66 other events

Deaths: 0 deaths

OLE Period: Difelikefalin/Difelikefalin

Serious events: 19 serious events

Other events: 65 other events

Deaths: 0 deaths

OLE Period: Placebo/Difelikefalin

Serious events: 12 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	DB Period: Difelikefalin n=129 participants at risk Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total).	DB Period: Placebo n=130 participants at risk Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total).	OLE Period: Difelikefalin/Difelikefalin n=103 participants at risk Upon completion of the double-blind period, participants who received Difelikefalin in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.	OLE Period: Placebo/Difelikefalin n=113 participants at risk Upon completion of the double-blind period, participants who received placebo in DB period, who chose to enter the optional OLE period, received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive.
Metabolism and nutrition disorders Hyperkalaemia	16.3% 21/129 • Number of events 27 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	16.2% 21/130 • Number of events 25 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	19.4% 20/103 • Number of events 32 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	18.6% 21/113 • Number of events 34 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Metabolism and nutrition disorders Hypocalcaemia	2.3% 3/129 • Number of events 3 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	1.5% 2/130 • Number of events 3 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.8% 7/103 • Number of events 7 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	1.8% 2/113 • Number of events 2 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Metabolism and nutrition disorders Hypercalcaemia	1.6% 2/129 • Number of events 2 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	0.77% 1/130 • Number of events 1 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	4.9% 5/103 • Number of events 5 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	5.3% 6/113 • Number of events 6 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Vascular disorders Dialysis hypotension	14.7% 19/129 • Number of events 71 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.9% 9/130 • Number of events 26 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	12.6% 13/103 • Number of events 55 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	14.2% 16/113 • Number of events 63 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Vascular disorders Hypotension	16.3% 21/129 • Number of events 29 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.2% 8/130 • Number of events 11 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	10.7% 11/103 • Number of events 12 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	13.3% 15/113 • Number of events 28 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	10.1% 13/129 • Number of events 15 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	10.8% 14/130 • Number of events 16 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	8.7% 9/103 • Number of events 9 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	9.7% 11/113 • Number of events 14 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	14.0% 18/129 • Number of events 39 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	8.5% 11/130 • Number of events 15 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	10.7% 11/103 • Number of events 30 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	13.3% 15/113 • Number of events 33 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Cardiac disorders Tachycardia	4.7% 6/129 • Number of events 16 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	4.6% 6/130 • Number of events 37 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	2.9% 3/103 • Number of events 4 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	8.0% 9/113 • Number of events 48 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Cardiac disorders Palpitations	6.2% 8/129 • Number of events 10 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	3.8% 5/130 • Number of events 7 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	3.9% 4/103 • Number of events 4 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.2% 7/113 • Number of events 11 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	4.7% 6/129 • Number of events 6 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	4.6% 6/130 • Number of events 6 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.8% 7/103 • Number of events 7 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	2.7% 3/113 • Number of events 3 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Gastrointestinal disorders Constipation	7.0% 9/129 • Number of events 11 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	3.1% 4/130 • Number of events 4 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	3.9% 4/103 • Number of events 4 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	0.88% 1/113 • Number of events 3 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Nervous system disorders Dizziness	12.4% 16/129 • Number of events 18 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	6.2% 8/130 • Number of events 16 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	5.8% 6/103 • Number of events 7 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	5.3% 6/113 • Number of events 9 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 4/129 • Number of events 5 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	5.4% 7/130 • Number of events 8 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	5.8% 6/103 • Number of events 8 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	1.8% 2/113 • Number of events 2 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Psychiatric disorders Insomnia	5.4% 7/129 • Number of events 10 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	3.1% 4/130 • Number of events 5 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	0.97% 1/103 • Number of events 1 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.	1.8% 2/113 • Number of events 2 • From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up) The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.

Additional Information

Clinical Study Disclosure Manager

CSL Behring

Phone: Use email contact

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place