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Clinical Trial Results:
Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and safety study of 12-week twice daily oral administration of BAY 1817080 compared to placebo in the treatment of refractory and/or unexplained chronic cough (RUCC)

Summary
EudraCT number	2019-004169-42
Trial protocol	DE GB IT NL CZ HU SK BE PL FR
Global end of trial date	23 Jul 2021

Results information
Results version number	v1(current)
This version publication date	04 Jul 2022
First version publication date	04 Jul 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

BAY1817080/20393

ISRCTN number

-

US NCT number

NCT04562155

WHO universal trial number (UTN)

-

Sponsor organisation name

Bayer AG

Sponsor organisation address

Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368

Public contact

Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com

Scientific contact

Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

23 Jul 2021

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

23 Jul 2021

Was the trial ended prematurely?

No

Main objective of the trial

The objective of this study was to identify the optimal dose of P2X3 receptor antagonist eliapixant in patients with RUCC and further assess efficacy and characterize safety and tolerability profile of eliapixant. The primary objective was to assess the efficacy of P2X3 receptor antagonist eliapixant as compared with placebo in terms of change in 24-hour cough count from baseline to week 12.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

02 Oct 2020

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 12

Country: Number of subjects enrolled

Australia: 26

Country: Number of subjects enrolled

Belgium: 20

Country: Number of subjects enrolled

Canada: 8

Country: Number of subjects enrolled

Czechia: 12

Country: Number of subjects enrolled

Germany: 28

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

France: 11

Country: Number of subjects enrolled

United Kingdom: 26

Country: Number of subjects enrolled

Hungary: 12

Country: Number of subjects enrolled

Italy: 10

Country: Number of subjects enrolled

Japan: 23

Country: Number of subjects enrolled

Netherlands: 12

Country: Number of subjects enrolled

Poland: 20

Country: Number of subjects enrolled

Russian Federation: 16

Country: Number of subjects enrolled

Slovakia: 9

Country: Number of subjects enrolled

Turkey: 17

Country: Number of subjects enrolled

Taiwan: 6

Country: Number of subjects enrolled

United States: 33

Worldwide total number of subjects

310

EEA total number of subjects

143

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

193

From 65 to 84 years

117

85 years and over

0

Subject disposition

Top of page

Recruitment details

The study was conducted at 99 centers in 19 countries/regions with first subject first visit on 02-Oct-2020 and last subject last visit on 23-Jul-2021.

Screening details

Overall, 399 subjects were screened, 89 of whom were screening failures. The remaining 310 subjects were randomized to 4 treatment groups (75 to eliapixant 25 mg BID, 78 to eliapixant 75 mg BID, 80 to eliapixant 150 mg BID, and 77 to placebo).

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

After randomization, subject, investigator and sponsor were blinded for the intervention subject received

Are arms mutually exclusive

Yes

Eliapixant 25 mg BID

Arm description

Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Eliapixant

Investigational medicinal product code

BAY1817080

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Eliapixant 25 mg tablets were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

Eliapixant 75 mg BID

Arm description

Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Eliapixant

Investigational medicinal product code

BAY1817080

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Eliapixant tablets totaling 75 mg were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

Eliapixant 150 mg BID

Arm description

Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Eliapixant

Investigational medicinal product code

BAY1817080

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Eliapixant tablets totaling 150 mg were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food. There were no dose modifications; subjects stayed on the dose which they were randomized to.

Placebo

Arm description

Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo for eliapixant

Investigational medicinal product code

Not applicable

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Placebo for eliapixant tablets were administered twice daily. Subjects were instructed to take the morning dose at approximately the same time of day, every day over the course of 12 weeks. The interval between the morning and the evening dose should have been approximately 12 hours. Tablets were not to be broken, halved or crushed; they were to be swallowed as a complete unit with water. Tablets could be taken with or without food.

Number of subjects in period 1	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Started	75	78	80	77
Completed	64	69	67	71
Not completed	11	9	13	6
COVID-19 pandemic	-	-	-	1
Consent withdrawn by subject	3	6	3	3
Adverse event, non-fatal	7	3	8	1
Other	1	-	2	1

Baseline characteristics

Top of page

Reporting group title

Eliapixant 25 mg BID

Reporting group description

Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 75 mg BID

Reporting group description

Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 150 mg BID

Reporting group description

Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Placebo

Reporting group description

Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

Reporting group values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo	Total
Number of subjects	75	78	80	77	310
Age categorical
Used full analysis set
Units: Subjects
Adults (18-64 years)	45	50	49	49	193
From 65-84 years	30	28	31	28	117
Age continuous
Used full analysis set
Units: years
arithmetic mean (standard deviation)	61.81 ± 9.64	58.62 ± 12.7	58.98 ± 11.8	56.91 ± 12.4	-
Gender categorical
Used full analysis set
Units: Subjects
Female	56	63	61	61	241
Male	19	15	19	16	69
Baseline 24-hour coughs per hour
Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
Units: 24-hour cough count per hour
geometric mean (standard deviation)	17.49 ± 2.94	19.23 ± 2.94	15.61 ± 2.34	17.63 ± 3.07	-
Baseline Leicester Cough Questionnaire (LCQ) Total Score
Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
Units: Score of LCQ
arithmetic mean (standard deviation)	12.00 ± 2.54	11.76 ± 2.77	11.15 ± 2.56	11.53 ± 3.27	-
Baseline awake cough count per hour
Used per protocol set (PPS) Eliapixant 25 mg BID (N=67), Eliapixant 75 mg BID (N=69), Eliapixant 150 mg BID (N=73), Placebo (N=74)
Units: Cough count per hour
geometric mean (standard deviation)	23.62 ± 3.02	26.41 ± 2.97	21.19 ± 2.39	24.01 ± 3.18	-
Baseline Cough Severity Visual Analogue Scale [VAS] Value
Used per protocol set (PPS) - Included the subjects in PPS with valid VAS value. Eliapixant 25 mg BID (N=62), Eliapixant 75 mg BID (N=68), Eliapixant 150 mg BID (N=67), Placebo (N=69)
Units: Score of VAS
arithmetic mean (standard deviation)	65.51 ± 14.64	67.08 ± 14.89	66.79 ± 15.86	61.52 ± 18.51	-

End points

Top of page

Reporting group title

Eliapixant 25 mg BID

Reporting group description

Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 75 mg BID

Reporting group description

Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 150 mg BID

Reporting group description

Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Placebo

Reporting group description

Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

Subject analysis set title

Full analysis set (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

All subjects randomly assigned to study intervention. Subjects were analyzed according to the intervention they were randomized to.

Subject analysis set title

Safety analysis set (SAF)

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects randomly assigned to study intervention and who took at least one tablet of study intervention. Subjects were analyzed according to the intervention they actually received.

Subject analysis set title

Per protocol set (PPS)

Subject analysis set type

Per protocol

Subject analysis set description

All subjects randomly assigned to study intervention who did not have validity findings affecting efficacy. subjects were analyzed according to the intervention they actually received. If a subject received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the subjects from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 subjects, 4.8%) or that the subject had used prohibited concomitant medication (9 subjects, 2.9%).

Primary: Change from baseline in 24-hour cough count after 12 weeks of intervention

Top of page

End point title

Change from baseline in 24-hour cough count after 12 weeks of intervention

End point description

Measured by cough recording digital wearable monitoring device. btw = between geo = geometric

End point type

Primary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	64 ^[1]	68 ^[2]	72 ^[3]	73 ^[4]
Units: Ratio btw geoMeans of 24h cough count
geometric mean (standard deviation)	0.56 ± 0.9191	0.47 ± 0.9019	0.52 ± 0.8608	0.64 ± 0.7855

Notes
[1] - PPS
[2] - PPS
[3] - PPS
[4] - PPS

Detection of dose-response: Emax model (ED50=30)

Statistical analysis description

Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).

Comparison groups

Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID

Number of subjects included in analysis

277

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0345 ^[5]

Method

MCP-Mod method

Confidence interval

Notes
[5] - Adjusted p-value

DoD: sigm. Emax model (ED50=30, h=3)

Statistical analysis description

DoD = Detection of dose-response sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).

Comparison groups

Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID

Number of subjects included in analysis

277

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0319 ^[6]

Method

MCP-Mod method

Confidence interval

Notes
[6] - Adjusted p-value

DoD: sigm. Emax model (ED50=60, h=5)

Statistical analysis description

DoD = Detection of dose-response sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).

Comparison groups

Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID

Number of subjects included in analysis

277

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0603 ^[7]

Method

MCP-Mod method

Confidence interval

Notes
[7] - Adjusted p-value

Detection of dose-response: Emax model (ED50=50)

Statistical analysis description

Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).

Comparison groups

Placebo v Eliapixant 25 mg BID v Eliapixant 75 mg BID v Eliapixant 150 mg BID

Number of subjects included in analysis

277

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0376 ^[8]

Method

MCP-Mod method

Confidence interval

Notes
[8] - Adjusted p-value

Secondary: Percentage of subjects with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention

Top of page

End point title

Percentage of subjects with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention

End point description

Measured by cough recording digital wearable monitoring device

End point type

Secondary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[9]	69 ^[10]	73 ^[11]	74 ^[12]
Units: Percentage
number (confidence interval 95%)	52.24 (39.67 to 64.60)	63.77 (51.31 to 75.01)	53.42 (41.37 to 65.20)	45.95 (34.29 to 57.93)

Notes
[9] - PPS
[10] - PPS
[11] - PPS
[12] - PPS

No statistical analyses for this end point

Secondary: Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention

Top of page

End point title

Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention

End point description

Measured by cough recording digital wearable monitoring device btw = between geo = geometric Number of subjects analysed at Week 2: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=67), Eliapixant 150 mg BID (N=72), Placebo (N=73) Number of subjects analysed at Week 4: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=66), Eliapixant 150 mg BID (N=68), Placebo (N=71) Number of subjects analysed at Week 8: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=65), Eliapixant 150 mg BID (N=69), Placebo (N=72)

End point type

Secondary

End point timeframe

From baseline up to 2 weeks, 4 weeks and 8 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[13]	69 ^[14]	73 ^[15]	74 ^[16]
Units: Ratio btw geoMeans of 24h cough count
geometric mean (standard deviation)
Week 2	0.75 ± 0.6134	0.58 ± 0.8209	0.61 ± 0.6636	0.75 ± 0.4762
Week 4	0.64 ± 0.7237	0.51 ± 0.8192	0.58 ± 0.8589	0.69 ± 0.6657
Week 8	0.55 ± 0.8737	0.46 ± 0.9484	0.51 ± 0.8827	0.70 ± 0.6451

Notes
[13] - PPS
[14] - PPS
[15] - PPS
[16] - PPS

No statistical analyses for this end point

Secondary: Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention

Top of page

End point title

Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention

End point description

Measured by cough recording digital wearable monitoring device btw = between geo = geometric Number of subjects analysed at Week 2: Eliapixant 25 mg BID (N=65), Eliapixant 75 mg BID (N=67), Eliapixant 150 mg BID (N=72), Placebo (N=73) Number of subjects analysed at Week 4: Eliapixant 25 mg BID (N=66), Eliapixant 75 mg BID (N=66), Eliapixant 150 mg BID (N=68), Placebo (N=71) Number of subjects analysed at Week 8: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=65), Eliapixant 150 mg BID (N=69), Placebo (N=72) Number of subjects analysed at Week 12: Eliapixant 25 mg BID (N=64), Eliapixant 75 mg BID (N=68), Eliapixant 150 mg BID (N=72), Placebo (N=73)

End point type

Secondary

End point timeframe

From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[17]	69 ^[18]	73 ^[19]	74 ^[20]
Units: Ratio btw geoMeans of 24h cough count
geometric mean (standard deviation)
Week 2	0.78 ± 0.6324	0.60 ± 0.8295	0.60 ± 0.6695	0.77 ± 0.4660
Week 4	0.67 ± 0.7390	0.53 ± 0.8128	0.57 ± 0.8983	0.72 ± 0.6637
Week 8	0.55 ± 0.9274	0.47 ± 0.9576	0.50 ± 0.9154	0.72 ± 0.6698
Week 12	0.56 ± 0.9582	0.47 ± 0.9051	0.47 ± 1.1338	0.65 ± 0.7926

Notes
[17] - PPS
[18] - PPS
[19] - PPS
[20] - PPS

No statistical analyses for this end point

Secondary: Change from baseline in cough related quality of life after 12 weeks of intervention

Top of page

End point title

Change from baseline in cough related quality of life after 12 weeks of intervention

End point description

Measured by Leicester Cough Questionnaire [LCQ]

End point type

Secondary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[21]	69 ^[22]	73 ^[23]	74 ^[24]
Units: Score of the Questionnaire
arithmetic mean (standard deviation)	2.18 ± 3.44	2.50 ± 3.29	2.73 ± 3.53	2.16 ± 3.12

Notes
[21] - PPS
[22] - PPS
[23] - PPS
[24] - PPS

No statistical analyses for this end point

Secondary: Change from baseline in cough severity after 12 weeks of intervention

Top of page

End point title

Change from baseline in cough severity after 12 weeks of intervention

End point description

Measured by Cough Severity Visual Analogue Scale [VAS]

End point type

Secondary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	61 ^[25]	68 ^[26]	67 ^[27]	68 ^[28]
Units: Score of VAS
arithmetic mean (standard deviation)	-17.69 ± 23.87	-22.66 ± 22.98	-22.87 ± 24.54	-17.02 ± 21.88

Notes
[25] - PPS
[26] - PPS
[27] - PPS
[28] - PPS

No statistical analyses for this end point

Secondary: Percentage of subjects with a ≥30 scale units reduction from baseline after 12 weeks of intervention

Top of page

End point title

Percentage of subjects with a ≥30 scale units reduction from baseline after 12 weeks of intervention

End point description

Measured by cough Severity VAS

End point type

Secondary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[29]	69 ^[30]	73 ^[31]	74 ^[32]
Units: Percentage
number (confidence interval 95%)	26.87 (16.76 to 39.10)	36.23 (24.99 to 48.69)	27.40 (17.61 to 39.09)	20.27 (11.81 to 31.22)

Notes
[29] - PPS
[30] - PPS
[31] - PPS
[32] - PPS

No statistical analyses for this end point

Secondary: Percentage of subjects with a ≥1.3-point increase from baseline after 12 weeks of intervention

Top of page

End point title

Percentage of subjects with a ≥1.3-point increase from baseline after 12 weeks of intervention

End point description

Measured with LCQ Total Score

End point type

Secondary

End point timeframe

From baseline up to 12 weeks

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	67 ^[33]	69 ^[34]	73 ^[35]	74 ^[36]
Units: Percentage
number (confidence interval 95%)	47.76 (35.40 to 60.33)	60.87 (48.37 to 72.40)	64.38 (52.31 to 75.25)	51.35 (39.44 to 63.15)

Notes
[33] - PPS
[34] - PPS
[35] - PPS
[36] - PPS

No statistical analyses for this end point

Secondary: Number of subjects with treatment-emergent adverse events (TEAEs) and associated severity

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End point title

Number of subjects with treatment-emergent adverse events (TEAEs) and associated severity

End point description

End point type

Secondary

End point timeframe

From the start of study intervention administration until 14 days after the last study medication intake

End point values	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Number of subjects analysed	75 ^[37]	78 ^[38]	80 ^[39]	77 ^[40]
Units: Subjects
Any TEAE	43	51	51	39
Maximum intensity for any TEAE - mild	21	32	23	18
Maximum intensity for any TEAE - moderate	22	16	25	20
Maximum intensity for any TEAE - severe	0	3	3	1
Any serious TEAE	0	1	2	1

Notes
[37] - SAF
[38] - SAF
[39] - SAF
[40] - SAF

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From the start of study intervention administration until 14 days after the last study medication intake

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Eliapixant 25 mg BID

Reporting group description

Subjects were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 75 mg BID

Reporting group description

Subjects were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Eliapixant 150 mg BID

Reporting group description

Subjects were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.

Reporting group title

Placebo

Reporting group description

Subjects were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.

Serious adverse events	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 75 (0.00%)	1 / 78 (1.28%)	2 / 80 (2.50%)	1 / 77 (1.30%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Investigations
Liver function test abnormal
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	1 / 80 (1.25%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Lumbar vertebral fracture
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	1 / 80 (1.25%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Angina unstable
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	0 / 80 (0.00%)	1 / 77 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 75 (0.00%)	1 / 78 (1.28%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Eliapixant 25 mg BID	Eliapixant 75 mg BID	Eliapixant 150 mg BID	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	32 / 75 (42.67%)	37 / 78 (47.44%)	45 / 80 (56.25%)	25 / 77 (32.47%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 75 (0.00%)	1 / 78 (1.28%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	0	1	2	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	0	0	2	0
Blood fibrinogen increased
subjects affected / exposed	1 / 75 (1.33%)	1 / 78 (1.28%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	1	1	2	0
Weight increased
subjects affected / exposed	1 / 75 (1.33%)	1 / 78 (1.28%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	1	1	2	0
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	0 / 75 (0.00%)	2 / 78 (2.56%)	0 / 80 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	2	0	1
Nervous system disorders
Ageusia
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	0	0	2	1
Dizziness
subjects affected / exposed	2 / 75 (2.67%)	2 / 78 (2.56%)	1 / 80 (1.25%)	5 / 77 (6.49%)
occurrences all number	2	2	1	5
Dysgeusia
subjects affected / exposed	1 / 75 (1.33%)	9 / 78 (11.54%)	13 / 80 (16.25%)	1 / 77 (1.30%)
occurrences all number	1	9	14	1
Headache
subjects affected / exposed	6 / 75 (8.00%)	5 / 78 (6.41%)	6 / 80 (7.50%)	4 / 77 (5.19%)
occurrences all number	6	10	7	4
Hypogeusia
subjects affected / exposed	2 / 75 (2.67%)	1 / 78 (1.28%)	4 / 80 (5.00%)	2 / 77 (2.60%)
occurrences all number	2	1	4	2
Balance disorder
subjects affected / exposed	0 / 75 (0.00%)	1 / 78 (1.28%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	0	1	2	0
Taste disorder
subjects affected / exposed	0 / 75 (0.00%)	2 / 78 (2.56%)	1 / 80 (1.25%)	1 / 77 (1.30%)
occurrences all number	0	2	1	1
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	2 / 75 (2.67%)	1 / 78 (1.28%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences all number	2	1	0	0
Fatigue
subjects affected / exposed	2 / 75 (2.67%)	6 / 78 (7.69%)	5 / 80 (6.25%)	2 / 77 (2.60%)
occurrences all number	2	6	6	2
Oedema peripheral
subjects affected / exposed	0 / 75 (0.00%)	2 / 78 (2.56%)	1 / 80 (1.25%)	0 / 77 (0.00%)
occurrences all number	0	2	1	0
Pyrexia
subjects affected / exposed	3 / 75 (4.00%)	0 / 78 (0.00%)	0 / 80 (0.00%)	1 / 77 (1.30%)
occurrences all number	3	0	0	1
Swelling face
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences all number	2	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	0	0	2	1
Abdominal pain upper
subjects affected / exposed	3 / 75 (4.00%)	3 / 78 (3.85%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	3	3	2	1
Diarrhoea
subjects affected / exposed	3 / 75 (4.00%)	2 / 78 (2.56%)	1 / 80 (1.25%)	1 / 77 (1.30%)
occurrences all number	3	2	1	1
Dry mouth
subjects affected / exposed	1 / 75 (1.33%)	3 / 78 (3.85%)	2 / 80 (2.50%)	4 / 77 (5.19%)
occurrences all number	1	3	2	5
Flatulence
subjects affected / exposed	2 / 75 (2.67%)	1 / 78 (1.28%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences all number	2	1	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 75 (1.33%)	2 / 78 (2.56%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	1	2	2	0
Nausea
subjects affected / exposed	2 / 75 (2.67%)	2 / 78 (2.56%)	5 / 80 (6.25%)	1 / 77 (1.30%)
occurrences all number	2	3	5	2
Vomiting
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	3 / 80 (3.75%)	0 / 77 (0.00%)
occurrences all number	0	0	3	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	4 / 75 (5.33%)	7 / 78 (8.97%)	7 / 80 (8.75%)	3 / 77 (3.90%)
occurrences all number	4	7	7	3
Nasal dryness
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	0 / 80 (0.00%)	2 / 77 (2.60%)
occurrences all number	0	0	0	3
Throat irritation
subjects affected / exposed	0 / 75 (0.00%)	1 / 78 (1.28%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	0	1	2	0
Oropharyngeal pain
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	1 / 80 (1.25%)	0 / 77 (0.00%)
occurrences all number	2	0	1	0
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	3 / 75 (4.00%)	0 / 78 (0.00%)	1 / 80 (1.25%)	2 / 77 (2.60%)
occurrences all number	3	0	1	2
Rash
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	2 / 80 (2.50%)	0 / 77 (0.00%)
occurrences all number	2	0	4	0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 75 (1.33%)	2 / 78 (2.56%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	2	0	0
Insomnia
subjects affected / exposed	4 / 75 (5.33%)	0 / 78 (0.00%)	1 / 80 (1.25%)	0 / 77 (0.00%)
occurrences all number	4	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 75 (1.33%)	2 / 78 (2.56%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	2	2	2	1
Back pain
subjects affected / exposed	0 / 75 (0.00%)	0 / 78 (0.00%)	1 / 80 (1.25%)	2 / 77 (2.60%)
occurrences all number	0	0	1	2
Myalgia
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	0 / 80 (0.00%)	1 / 77 (1.30%)
occurrences all number	2	0	0	1
Pain in extremity
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	2 / 80 (2.50%)	2 / 77 (2.60%)
occurrences all number	2	0	2	2
Infections and infestations
Gastroenteritis
subjects affected / exposed	2 / 75 (2.67%)	0 / 78 (0.00%)	0 / 80 (0.00%)	0 / 77 (0.00%)
occurrences all number	3	0	0	0
Nasopharyngitis
subjects affected / exposed	2 / 75 (2.67%)	3 / 78 (3.85%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	2	3	3	1
Sinusitis
subjects affected / exposed	1 / 75 (1.33%)	0 / 78 (0.00%)	2 / 80 (2.50%)	1 / 77 (1.30%)
occurrences all number	1	0	2	1
Urinary tract infection
subjects affected / exposed	1 / 75 (1.33%)	2 / 78 (2.56%)	3 / 80 (3.75%)	0 / 77 (0.00%)
occurrences all number	1	2	3	0
COVID-19
subjects affected / exposed	2 / 75 (2.67%)	2 / 78 (2.56%)	0 / 80 (0.00%)	3 / 77 (3.90%)
occurrences all number	2	2	0	3

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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