Trial Outcomes & Findings for Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia (NCT NCT04147858)

NCT ID: NCT04147858

Last Updated: 2023-04-28

Results Overview

Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 310 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2023-04-28

Participant Flow

Participant milestones

Measure	NYX-2925 50 mg NYX-2925 50 mg administered orally.	NYX-2925 100 mg NYX-2925 100 mg administered orally.	Placebo Placebo administered orally.
Overall Study STARTED	101	104	105
Overall Study COMPLETED	84	82	85
Overall Study NOT COMPLETED	17	22	20

Reasons for withdrawal

Measure	NYX-2925 50 mg NYX-2925 50 mg administered orally.	NYX-2925 100 mg NYX-2925 100 mg administered orally.	Placebo Placebo administered orally.
Overall Study Adverse Event	6	6	6
Overall Study Lack of Efficacy	3	3	1
Overall Study Lost to Follow-up	1	6	2
Overall Study Withdrawal by Subject	3	4	10
Overall Study Subject Noncompliance, Other	4	3	1

Baseline Characteristics

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Baseline characteristics by cohort

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=105 Participants Placebo administered orally once daily.	Total n=310 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 12.81 • n=5 Participants	51.8 years STANDARD_DEVIATION 13.45 • n=7 Participants	53.1 years STANDARD_DEVIATION 12.28 • n=5 Participants	52.7 years STANDARD_DEVIATION 12.83 • n=4 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	99 Participants n=7 Participants	96 Participants n=5 Participants	289 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	77 Participants n=7 Participants	83 Participants n=5 Participants	227 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	88 Participants n=7 Participants	84 Participants n=5 Participants	259 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	101 participants n=5 Participants	104 participants n=7 Participants	105 participants n=5 Participants	310 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Change in the Mean Numerical Rating Scale (NRS) Score	-1.26 units on a scale Standard Deviation 1.603	-1.47 units on a scale Standard Deviation 1.983	-1.23 units on a scale Standard Deviation 1.846

SECONDARY outcome

Timeframe: Week 12

Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12	22 Participants	24 Participants	24 Participants

SECONDARY outcome

Timeframe: Week 12

Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Daily Sleep Interference (DSIS) Score	-1.42 units on a scale Standard Deviation 1.835	-1.45 units on a scale Standard Deviation 2.104	-1.38 units on a scale Standard Deviation 2.177

SECONDARY outcome

Timeframe: Week 12

Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Number of Subjects Achieving ≥30% Pain Reduction	30 Participants	34 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 12

Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Number of Subjects Achieving ≥50% Pain Reduction	13 Participants	15 Participants	13 Participants

SECONDARY outcome

Timeframe: Week 12

Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score	-12.6 units on a scale Standard Deviation 20.10	-12.3 units on a scale Standard Deviation 20.56	-9.9 units on a scale Standard Deviation 20.08

SECONDARY outcome

Timeframe: Week 12

Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score	-3.59 units on a scale Standard Deviation 8.238	-3.93 units on a scale Standard Deviation 8.346	-4.66 units on a scale Standard Deviation 9.567

SECONDARY outcome

Timeframe: Week 12

Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score	-3.5 units on a scale Standard Deviation 8.70	-3.7 units on a scale Standard Deviation 9.04	-2.9 units on a scale Standard Deviation 7.90

SECONDARY outcome

Timeframe: Week 12

Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score	2.18 units on a scale Standard Deviation 5.017	2.08 units on a scale Standard Deviation 5.223	1.83 units on a scale Standard Deviation 5.153

SECONDARY outcome

Timeframe: Week 12

The number of subjects using rescue medication.

Outcome measures

Measure	NYX-2925 50 mg n=101 Participants NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 Participants NYX-2925 100 mg administered orally once daily.	Placebo n=104 Participants Placebo administered orally once daily.
Use of Rescue Medication	93 Participants	87 Participants	88 Participants

Adverse Events

NYX-2925 50 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

NYX-2925 100 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	NYX-2925 50 mg n=101 participants at risk NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 participants at risk NYX-2925 100 mg administered orally once daily.	Placebo n=105 participants at risk Placebo administered orally once daily.
Gastrointestinal disorders Diarrhea	0.00% 0/101 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	0.96% 1/104 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	0.00% 0/105 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
Infections and infestations COVID-19	0.00% 0/101 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	0.96% 1/104 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	0.00% 0/105 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)

Other adverse events

Measure	NYX-2925 50 mg n=101 participants at risk NYX-2925 50 mg administered orally once daily.	NYX-2925 100 mg n=104 participants at risk NYX-2925 100 mg administered orally once daily.	Placebo n=105 participants at risk Placebo administered orally once daily.
Gastrointestinal disorders Diarrhea	4.0% 4/101 • Number of events 4 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	1.9% 2/104 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	2.9% 3/105 • Number of events 3 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
Gastrointestinal disorders Nausea	5.0% 5/101 • Number of events 5 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	3.8% 4/104 • Number of events 4 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	8.6% 9/105 • Number of events 11 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
General disorders Fatigue	3.0% 3/101 • Number of events 3 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	0.96% 1/104 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	2.9% 3/105 • Number of events 4 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
Infections and infestations COVID-19	2.0% 2/101 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	5.8% 6/104 • Number of events 6 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	3.8% 4/105 • Number of events 4 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
Infections and infestations Urinary tract infection	2.0% 2/101 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	5.8% 6/104 • Number of events 7 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	1.9% 2/105 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)
Nervous system disorders Headache	7.9% 8/101 • Number of events 8 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	3.8% 4/104 • Number of events 4 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)	3.8% 4/105 • Number of events 5 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event. MedDRA (24.1)

Additional Information

Aptinyx Clinical Development

Aptinyx

Phone: 847-871-0377

Email: clinicalstudies@aptinyx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place