Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough (NCT NCT04562155)

Last Updated: 2022-08-18

Results Overview

The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

310 participants

Primary outcome timeframe

From baseline up to 12 weeks

Results posted on

2022-08-18

Participant Flow

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

Overall, 399 participants were screened, 89 of whom were screening failures. The remaining 310 participatns 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).

Participant milestones

Participant milestones
Measure	Eliapixant 25 mg BID Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Overall Study STARTED	75	78	80	77
Overall Study COMPLETED	64	69	67	71
Overall Study NOT COMPLETED	11	9	13	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Eliapixant 25 mg BID Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Overall Study COVID-19 pandemic	0	0	0	1
Overall Study Adverse Event	7	3	8	1
Overall Study Withdrawal by Subject	3	6	3	3
Overall Study Participant personal reason	1	0	2	1

Baseline Characteristics

Used per protocol set (PPS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eliapixant 25 mg BID n=75 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=78 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=80 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=77 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.	Total n=310 Participants Total of all reporting groups
Age, Continuous	61.81 years STANDARD_DEVIATION 9.64 • n=75 Participants	58.62 years STANDARD_DEVIATION 12.7 • n=78 Participants	58.98 years STANDARD_DEVIATION 11.8 • n=80 Participants	56.91 years STANDARD_DEVIATION 12.4 • n=77 Participants	59.06 years STANDARD_DEVIATION 11.79 • n=310 Participants
Age, Customized Adults (18-64 years)	45 Participants n=75 Participants	50 Participants n=78 Participants	49 Participants n=80 Participants	49 Participants n=77 Participants	193 Participants n=310 Participants
Age, Customized From 65-84 years	30 Participants n=75 Participants	28 Participants n=78 Participants	31 Participants n=80 Participants	28 Participants n=77 Participants	117 Participants n=310 Participants
Sex: Female, Male Female	56 Participants n=75 Participants	63 Participants n=78 Participants	61 Participants n=80 Participants	61 Participants n=77 Participants	241 Participants n=310 Participants
Sex: Female, Male Male	19 Participants n=75 Participants	15 Participants n=78 Participants	19 Participants n=80 Participants	16 Participants n=77 Participants	69 Participants n=310 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=75 Participants	4 Participants n=78 Participants	3 Participants n=80 Participants	2 Participants n=77 Participants	10 Participants n=310 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=75 Participants	74 Participants n=78 Participants	77 Participants n=80 Participants	75 Participants n=77 Participants	300 Participants n=310 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=75 Participants	0 Participants n=78 Participants	0 Participants n=80 Participants	0 Participants n=77 Participants	0 Participants n=310 Participants
Baseline 24-hour coughs per hour	17.49 24-hour cough count per hour STANDARD_DEVIATION 2.94 • n=67 Participants • Used per protocol set (PPS)	19.23 24-hour cough count per hour STANDARD_DEVIATION 2.94 • n=69 Participants • Used per protocol set (PPS)	15.61 24-hour cough count per hour STANDARD_DEVIATION 2.34 • n=73 Participants • Used per protocol set (PPS)	17.63 24-hour cough count per hour STANDARD_DEVIATION 3.07 • n=74 Participants • Used per protocol set (PPS)	17.42 24-hour cough count per hour STANDARD_DEVIATION 2.81 • n=283 Participants • Used per protocol set (PPS)
Baseline Leicester Cough Questionnaire (LCQ) Total Score	12.00 Scores on a scale STANDARD_DEVIATION 2.54 • n=67 Participants • Used per protocol set (PPS)	11.76 Scores on a scale STANDARD_DEVIATION 2.77 • n=69 Participants • Used per protocol set (PPS)	11.15 Scores on a scale STANDARD_DEVIATION 2.56 • n=73 Participants • Used per protocol set (PPS)	11.53 Scores on a scale STANDARD_DEVIATION 3.27 • n=74 Participants • Used per protocol set (PPS)	11.60 Scores on a scale STANDARD_DEVIATION 2.81 • n=283 Participants • Used per protocol set (PPS)
Baseline awake cough count per hour	23.62 Cough count per hour STANDARD_DEVIATION 3.02 • n=67 Participants • Used per protocol set (PPS)	26.41 Cough count per hour STANDARD_DEVIATION 2.97 • n=69 Participants • Used per protocol set (PPS)	21.19 Cough count per hour STANDARD_DEVIATION 2.39 • n=73 Participants • Used per protocol set (PPS)	24.01 Cough count per hour STANDARD_DEVIATION 3.18 • n=74 Participants • Used per protocol set (PPS)	23.70 Cough count per hour STANDARD_DEVIATION 2.88 • n=283 Participants • Used per protocol set (PPS)
Baseline Cough Severity Visual Analogue Scale [VAS] Value	65.51 Scores on a scale STANDARD_DEVIATION 14.64 • n=62 Participants • Used per protocol set (PPS) - Included the participants in PPS with valid VAS value.	67.08 Scores on a scale STANDARD_DEVIATION 14.89 • n=68 Participants • Used per protocol set (PPS) - Included the participants in PPS with valid VAS value.	66.79 Scores on a scale STANDARD_DEVIATION 15.86 • n=67 Participants • Used per protocol set (PPS) - Included the participants in PPS with valid VAS value.	61.52 Scores on a scale STANDARD_DEVIATION 18.51 • n=69 Participants • Used per protocol set (PPS) - Included the participants in PPS with valid VAS value.	65.20 Scores on a scale STANDARD_DEVIATION 16.16 • n=266 Participants • Used per protocol set (PPS) - Included the participants in PPS with valid VAS value.

PRIMARY outcome

Timeframe: From baseline up to 12 weeks

Population: All participants in PPS with valid 24-hour cough count values in Week 12 or Termination visit.

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=64 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=68 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=72 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=73 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention	0.56 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9191 • Interval 0.9191 to	0.47 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9019 • Interval 0.9019 to	0.52 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8608 • Interval 0.8608 to	0.64 Ratio btw geoMeans of 24h cough count Standard Deviation 0.7855 • Interval 0.7855 to

SECONDARY outcome

Timeframe: From baseline up to 12 weeks

Population: PPS

The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. The change from baseline in 24-hour cough count was calculated by the geometric mean of 24-hour cough count after 12 weeks of intervention minus the geometric mean at baseline divided by the geometric mean at baseline. The percentage of participants with a reduction of ≥30% is shown

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=73 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention	52.24 Percentage of participants 95% Confidence Interval 39.67 • Interval 39.67 to 64.6	63.77 Percentage of participants 95% Confidence Interval 51.31 • Interval 51.31 to 75.01	53.42 Percentage of participants 95% Confidence Interval 41.37 • Interval 41.37 to 65.2	45.95 Percentage of participants 95% Confidence Interval 34.29 • Interval 34.29 to 57.93

SECONDARY outcome

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

Population: PPS

The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 2, 4, and 8 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=73 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention Week 2	0.75 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6134	0.58 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8209	0.61 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6636	0.75 Ratio btw geoMeans of 24h cough count Standard Deviation 0.4762
Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention Week 4	0.64 Ratio btw geoMeans of 24h cough count Standard Deviation 0.7237	0.51 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8192	0.58 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8589	0.69 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6657
Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention Week 8	0.55 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8737	0.46 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9484	0.51 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8827	0.70 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6451

SECONDARY outcome

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

Population: PPS

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

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=73 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention Week 2	0.78 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6324	0.60 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8295	0.60 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6695	0.77 Ratio btw geoMeans of 24h cough count Standard Deviation 0.4660
Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention Week 4	0.67 Ratio btw geoMeans of 24h cough count Standard Deviation 0.7390	0.53 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8128	0.57 Ratio btw geoMeans of 24h cough count Standard Deviation 0.8983	0.72 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6637
Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention Week 8	0.55 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9274	0.47 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9576	0.50 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9154	0.72 Ratio btw geoMeans of 24h cough count Standard Deviation 0.6698
Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention Week 12	0.56 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9582	0.47 Ratio btw geoMeans of 24h cough count Standard Deviation 0.9051	0.47 Ratio btw geoMeans of 24h cough count Standard Deviation 1.1338	0.65 Ratio btw geoMeans of 24h cough count Standard Deviation 0.7926

SECONDARY outcome

Timeframe: From baseline up to 12 weeks

Population: All participants in PPS with valid Leicester Cough Questionnaire scores in Week 12 or Termination visit were included.

Measured by Leicester Cough Questionnaire (LCQ) total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21.

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=72 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention	2.18 Scores on a scale Standard Deviation 3.44 • Interval 3.44 to	2.50 Scores on a scale Standard Deviation 3.29 • Interval 3.29 to	2.73 Scores on a scale Standard Deviation 3.53 • Interval 3.53 to	2.16 Scores on a scale Standard Deviation 3.12 • Interval 3.12 to

SECONDARY outcome

Timeframe: From baseline up to 12 weeks

Population: All participants in PPS with valid VAS scores in Week 12 or Termination visit.

Measured by Cough Severity Visual Analogue Scale (VAS). The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS. This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough".

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=61 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=68 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=67 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=68 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Change From Baseline in Cough Severity After 12 Weeks of Intervention	-17.69 Scores on a scale Standard Deviation 23.87 • Interval 23.87 to	-22.66 Scores on a scale Standard Deviation 22.98 • Interval 22.98 to	-22.87 Scores on a scale Standard Deviation 24.54 • Interval 24.54 to	-17.02 Scores on a scale Standard Deviation 21.88 • Interval 21.88 to

SECONDARY outcome

Timeframe: From baseline up to 12 weeks

Population: PPS

Measured by cough Severity VAS

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=73 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention	26.87 Percentage of participants 95% Confidence Interval 16.76 • Interval 16.76 to 39.1	36.23 Percentage of participants 95% Confidence Interval 24.99 • Interval 24.99 to 48.69	27.40 Percentage of participants 95% Confidence Interval 17.61 • Interval 17.61 to 39.09	20.27 Percentage of participants 95% Confidence Interval 11.81 • Interval 11.81 to 31.22

SECONDARY outcome

Timeframe: From baseline up to 12 weeks

Population: PPS

Measured by LCQ total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. The percentage of participants with a \>= 1.3-point increase in LCQ total score is shown.

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=67 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=69 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=73 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=74 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention	47.76 Percentage of participants 95% Confidence Interval 35.40 • Interval 35.4 to 60.33	60.87 Percentage of participants 95% Confidence Interval 48.37 • Interval 48.37 to 72.4	64.38 Percentage of participants 95% Confidence Interval 52.31 • Interval 52.31 to 75.25	51.35 Percentage of participants 95% Confidence Interval 39.44 • Interval 39.44 to 63.15

SECONDARY outcome

Timeframe: From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days

Population: Safety analysis set (SAF): All participants randomly assigned to study intervention and who took at least one tablet of study intervention. Participants were analyzed according to the intervention they actually received.

Adverse event (AE) was defined as any untoward medical occurrence in a study participant, whether or not considered related to the study intervention, occurring from the time of signing the informed consent until the follow-up visit. TEAE was defined as any event occurring or worsening after the start of study intervention administration until 14 days after the last intake of study intervention.

Outcome measures

Outcome measures
Measure	Eliapixant 25 mg BID n=75 Participants Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=78 Participants Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=80 Participants Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=77 Participants Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity Any TEAE	43 Participants	51 Participants	51 Participants	39 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity Maximum intensity for any TEAE - mild	21 Participants	32 Participants	23 Participants	18 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity Maximum intensity for any TEAE - moderate	22 Participants	16 Participants	25 Participants	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity Maximum intensity for any TEAE - severe	0 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity Any serious TEAE	0 Participants	1 Participants	2 Participants	1 Participants

Adverse Events

Eliapixant 25 mg BID

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Eliapixant 75 mg BID

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Eliapixant 150 mg BID

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eliapixant 25 mg BID n=75 participants at risk Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 75 mg BID n=78 participants at risk Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Eliapixant 150 mg BID n=80 participants at risk Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.	Placebo n=77 participants at risk Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks.
Cardiac disorders Angina unstable	0.00% 0/75 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/78 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/80 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	1.3% 1/77 • Number of events 1 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.
Infections and infestations Pneumonia	0.00% 0/75 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	1.3% 1/78 • Number of events 1 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/80 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/77 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/75 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/78 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	1.2% 1/80 • Number of events 1 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/77 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.
Investigations Liver function test abnormal	0.00% 0/75 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/78 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	1.2% 1/80 • Number of events 1 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.	0.00% 0/77 • From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.

Other adverse events

Additional Information

Therapeutic Area Head

Bayer AG

Phone: (+) 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60