Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain (NCT NCT05101317)
NCT ID: NCT05101317
Last Updated: 2025-12-26
Results Overview
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-12-26
Participant Flow
The study was conducted in China, the United States of America (USA), and Poland.Total of 310 subjects were screened, of which 142 subjects were randomized. Among them, 36 subjects received HMI-115 60 mg, 36 received HMI-115 120 mg, 35 received HMI-115 240 mg, and 35 subjects were randomized to receive placebo. In the protocol version 5.0, part 2 of the study was deleted and not executed. So no subject was recruited in the former planned part 2 study.
1\. Screening Period: up to 75 days prior to first dose * Screening Visit 1 * Screening Visit 2 (at least 35 days before Visit 3 to ensure at least 5 weeks Baseline pain score obtained before randomization)
Participant milestones
| Measure |
HMI-115 60mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Week1-13
STARTED
|
36
|
36
|
35
|
35
|
|
Week1-13
COMPLETED
|
36
|
33
|
35
|
34
|
|
Week1-13
NOT COMPLETED
|
0
|
3
|
0
|
1
|
|
Week 13-25
STARTED
|
36
|
33
|
35
|
34
|
|
Week 13-25
COMPLETED
|
35
|
30
|
33
|
34
|
|
Week 13-25
NOT COMPLETED
|
1
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
HMI-115 60mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Week1-13
Adverse Event
|
0
|
1
|
0
|
0
|
|
Week1-13
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Week1-13
Early Withdrawl
|
0
|
0
|
0
|
1
|
|
Week 13-25
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Week 13-25
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Week 13-25
Patient decide to have oral contraception/refuse to come back
|
0
|
2
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
Baseline characteristics by cohort
| Measure |
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
Total
n=108 Participants
Total of all reporting groups
|
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
|---|---|---|---|---|---|
|
Region of Enrollment
Poland
|
13 participants
n=30 Participants
|
14 participants
n=60 Participants
|
13 participants
n=219 Participants
|
54 participants
n=880 Participants
|
14 participants
n=30 Participants
|
|
Endometriosis duration
|
57.0 months
STANDARD_DEVIATION 31.8 • n=30 Participants
|
67.4 months
STANDARD_DEVIATION 28.7 • n=60 Participants
|
73.7 months
STANDARD_DEVIATION 27.2 • n=219 Participants
|
66.5 months
STANDARD_DEVIATION 31.7 • n=880 Participants
|
67.2 months
STANDARD_DEVIATION 37.8 • n=30 Participants
|
|
BMI
|
23.17 kg/m2
STANDARD_DEVIATION 3.220 • n=30 Participants
|
24.40 kg/m2
STANDARD_DEVIATION 4.046 • n=60 Participants
|
23.25 kg/m2
STANDARD_DEVIATION 4.223 • n=219 Participants
|
23.57 kg/m2
STANDARD_DEVIATION 3.873 • n=880 Participants
|
23.57 kg/m2
STANDARD_DEVIATION 4.011 • n=30 Participants
|
|
DYS NRS
|
6.393 units on a scale
STANDARD_DEVIATION 2.1123 • n=30 Participants
|
5.910 units on a scale
STANDARD_DEVIATION 1.8236 • n=60 Participants
|
5.696 units on a scale
STANDARD_DEVIATION 2.0005 • n=219 Participants
|
6.127 units on a scale
STANDARD_DEVIATION 1.7909 • n=880 Participants
|
6.288 units on a scale
STANDARD_DEVIATION 1.4261 • n=30 Participants
|
|
NMPP NRS
|
3.985 units on a scale
STANDARD_DEVIATION 1.6538 • n=30 Participants
|
4.052 units on a scale
STANDARD_DEVIATION 2.0056 • n=60 Participants
|
3.643 units on a scale
STANDARD_DEVIATION 1.8806 • n=219 Participants
|
3.824 units on a scale
STANDARD_DEVIATION 1.8253 • n=880 Participants
|
3.662 units on a scale
STANDARD_DEVIATION 1.8258 • n=30 Participants
|
|
NSAIDs
|
1.481 pills
STANDARD_DEVIATION 1.7239 • n=30 Participants
|
1.411 pills
STANDARD_DEVIATION 1.4096 • n=60 Participants
|
1.112 pills
STANDARD_DEVIATION 1.1415 • n=219 Participants
|
1.307 pills
STANDARD_DEVIATION 1.3654 • n=880 Participants
|
1.283 pills
STANDARD_DEVIATION 1.2805 • n=30 Participants
|
|
Average Menstrual Bleeding Score
|
2.710 units on a scale
STANDARD_DEVIATION 0.7107 • n=30 Participants
|
2.722 units on a scale
STANDARD_DEVIATION 0.5610 • n=60 Participants
|
2.514 units on a scale
STANDARD_DEVIATION 0.5826 • n=219 Participants
|
2.629 units on a scale
STANDARD_DEVIATION 0.6060 • n=880 Participants
|
2.594 units on a scale
STANDARD_DEVIATION 0.5639 • n=30 Participants
|
|
Monthly Mean Endometriosis Daily Impact Pain Scale
DYS
|
2.281 units on a scale
STANDARD_DEVIATION 0.6385 • n=30 Participants
|
2.193 units on a scale
STANDARD_DEVIATION 0.5580 • n=60 Participants
|
2.122 units on a scale
STANDARD_DEVIATION 0.6031 • n=219 Participants
|
2.223 units on a scale
STANDARD_DEVIATION 0.5626 • n=880 Participants
|
2.303 units on a scale
STANDARD_DEVIATION 0.4370 • n=30 Participants
|
|
Monthly Mean Endometriosis Daily Impact Pain Scale
NMPP
|
1.529 units on a scale
STANDARD_DEVIATION 0.5878 • n=30 Participants
|
1.588 units on a scale
STANDARD_DEVIATION 0.6516 • n=60 Participants
|
1.435 units on a scale
STANDARD_DEVIATION 0.6191 • n=219 Participants
|
1.481 units on a scale
STANDARD_DEVIATION 0.6102 • n=880 Participants
|
1.390 units on a scale
STANDARD_DEVIATION 0.6000 • n=30 Participants
|
|
Monthly Mean Endometriosis Daily Impact Pain Scale
DYSP
|
1.158 units on a scale
STANDARD_DEVIATION 0.9168 • n=30 Participants
|
1.102 units on a scale
STANDARD_DEVIATION 0.8189 • n=60 Participants
|
1.358 units on a scale
STANDARD_DEVIATION 0.6214 • n=219 Participants
|
1.149 units on a scale
STANDARD_DEVIATION 0.7483 • n=880 Participants
|
0.906 units on a scale
STANDARD_DEVIATION 0.6429 • n=30 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 4.99 • n=30 Participants
|
37.4 years
STANDARD_DEVIATION 5.31 • n=60 Participants
|
38.1 years
STANDARD_DEVIATION 5.17 • n=219 Participants
|
38.0 years
STANDARD_DEVIATION 5.05 • n=880 Participants
|
39.9 years
STANDARD_DEVIATION 4.43 • n=30 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
30 Participants
n=219 Participants
|
108 Participants
n=880 Participants
|
27 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
29 Participants
n=219 Participants
|
106 Participants
n=880 Participants
|
26 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
15 Participants
n=219 Participants
|
49 Participants
n=880 Participants
|
12 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
15 Participants
n=219 Participants
|
58 Participants
n=880 Participants
|
15 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=30 Participants
|
1 participants
n=60 Participants
|
2 participants
n=219 Participants
|
5 participants
n=880 Participants
|
1 participants
n=30 Participants
|
|
Region of Enrollment
China
|
13 participants
n=30 Participants
|
9 participants
n=60 Participants
|
15 participants
n=219 Participants
|
49 participants
n=880 Participants
|
12 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
|
-27.35 percentage of change from baseline
Standard Error 9.568
|
-34.72 percentage of change from baseline
Standard Error 9.630
|
-41.57 percentage of change from baseline
Standard Error 10.234
|
-18.61 percentage of change from baseline
Standard Error 8.859
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized subjects with at least 1 dose with surgical diagnosis
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change）
|
-2.57 score on a scale
Standard Error 0.542
|
-3.29 score on a scale
Standard Error 0.546
|
-3.26 score on a scale
Standard Error 0.579
|
-2.31 score on a scale
Standard Error 0.502
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: PAS: All randomized subjects who had at least 1 dose with surgical diagnosis
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)
|
-6.86 percentage of change from baseline
Standard Error 11.912
|
-21.82 percentage of change from baseline
Standard Error 12.039
|
-14.07 percentage of change from baseline
Standard Error 12.736
|
3.97 percentage of change from baseline
Standard Error 10.898
|
SECONDARY outcome
Timeframe: Baseline, week 12 and 24Population: PAS: All randomized subjects with at least 1 dose with Surgical diagnosis
The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)
Week24 %CFB
|
-11.22 percentage of change from baseline
Standard Error 15.063
|
-56.62 percentage of change from baseline
Standard Error 15.252
|
-38.05 percentage of change from baseline
Standard Error 16.341
|
-33.30 percentage of change from baseline
Standard Error 13.800
|
|
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)
Week12 %CFB
|
-33.74 percentage of change from baseline
Standard Error 10.283
|
-47.48 percentage of change from baseline
Standard Error 10.363
|
-51.66 percentage of change from baseline
Standard Error 11.157
|
-27.61 percentage of change from baseline
Standard Error 9.577
|
SECONDARY outcome
Timeframe: Baseline, week 12 and 24Population: All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints
The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=17 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=15 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=18 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=22 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)
Week12 %CFB
|
-7.01 percentage of change from baseline
Standard Error 19.073
|
-38.43 percentage of change from baseline
Standard Error 20.420
|
-11.70 percentage of change from baseline
Standard Error 22.342
|
-24.98 percentage of change from baseline
Standard Error 16.627
|
|
Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)
Week24 %CFB
|
-2.32 percentage of change from baseline
Standard Error 28.065
|
-61.91 percentage of change from baseline
Standard Error 30.048
|
3.47 percentage of change from baseline
Standard Error 30.259
|
-13.17 percentage of change from baseline
Standard Error 22.422
|
SECONDARY outcome
Timeframe: Baseline, week 12 and 24Population: All randomized subjects with at least 1 dose with surgical diagnosis
Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week 12 DYS
|
-0.83 score on a scale
Standard Error 0.184
|
-1.06 score on a scale
Standard Error 0.185
|
-1.13 score on a scale
Standard Error 0.197
|
-0.79 score on a scale
Standard Error 0.172
|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week 24 DYS
|
-0.60 score on a scale
Standard Error 0.192
|
-0.87 score on a scale
Standard Error 0.194
|
-0.66 score on a scale
Standard Error 0.205
|
-0.48 score on a scale
Standard Error 0.176
|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week12 NMPP
|
-0.49 score on a scale
Standard Error 0.119
|
-0.61 score on a scale
Standard Error 0.119
|
-0.69 score on a scale
Standard Error 0.128
|
-0.46 score on a scale
Standard Error 0.110
|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week24 NMPP
|
-0.42 score on a scale
Standard Error 0.162
|
-0.78 score on a scale
Standard Error 0.165
|
-0.63 score on a scale
Standard Error 0.178
|
-0.49 score on a scale
Standard Error 0.149
|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week12 DYSP
|
-0.01 score on a scale
Standard Error 0.169
|
-0.48 score on a scale
Standard Error 0.173
|
-0.16 score on a scale
Standard Error 0.187
|
-0.02 score on a scale
Standard Error 0.149
|
|
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Week24 DYSP
|
-0.19 score on a scale
Standard Error 0.210
|
-0.69 score on a scale
Standard Error 0.230
|
-0.28 score on a scale
Standard Error 0.222
|
-0.13 score on a scale
Standard Error 0.179
|
SECONDARY outcome
Timeframe: Baseline, week 12 and 24Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
Assessment was based on average pill counts at each apecific period od days
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use
CFB Week12 Average pill count Tier 1
|
-0.656 pill
Standard Deviation 1.4020
|
-0.463 pill
Standard Deviation 0.9113
|
-1.001 pill
Standard Deviation 1.4900
|
-0.384 pill
Standard Deviation 0.8579
|
|
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use
CFB Week24 Average pill count Tier1
|
-0.394 pill
Standard Deviation 1.4724
|
-0.643 pill
Standard Deviation 1.8192
|
-0.590 pill
Standard Deviation 1.1144
|
-0.414 pill
Standard Deviation 0.9968
|
SECONDARY outcome
Timeframe: Baseline, week 12 and 24Population: PAS:All ranomized subjects with at least 1 dose with surgical diagnosis
Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit
CFB Week 12 Average Score
|
-0.415 score on a scale
Standard Deviation 0.7062
|
-0.571 score on a scale
Standard Deviation 0.6114
|
-0.363 score on a scale
Standard Deviation 0.6437
|
-0.197 score on a scale
Standard Deviation 0.4525
|
|
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit
CFB Week 24 Average score
|
-0.119 score on a scale
Standard Deviation 0.6463
|
-0.390 score on a scale
Standard Deviation 0.8419
|
-0.585 score on a scale
Standard Deviation 0.6965
|
-0.114 score on a scale
Standard Deviation 0.4920
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)
|
-1.87 score on a scale
Standard Error 0.579
|
-2.95 score on a scale
Standard Error 0.585
|
-2.18 score on a scale
Standard Error 0.617
|
-1.45 score on a scale
Standard Error 0.529
|
SECONDARY outcome
Timeframe: Baseline, Week12, Week24Population: PAS: All randomized subjects with at least 1 dose with Surgical diagnosis
The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
Week12
|
-1.46 score on a scale
Standard Error 0.344
|
-1.64 score on a scale
Standard Error 0.347
|
-1.92 score on a scale
Standard Error 0.373
|
-1.36 score on a scale
Standard Error 0.321
|
|
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
Week24
|
-1.21 score on a scale
Standard Error 0.452
|
-2.07 score on a scale
Standard Error 0.457
|
-1.67 score on a scale
Standard Error 0.490
|
-1.26 score on a scale
Standard Error 0.415
|
SECONDARY outcome
Timeframe: Baseline, Week12, Week24Population: All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints
The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
HMI-115 60mg
n=17 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=15 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=18 Participants
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=22 Participants
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
Week12
|
-0.23 score on a scale
Standard Error 0.487
|
-1.33 score on a scale
Standard Error 0.489
|
-0.90 score on a scale
Standard Error 0.518
|
-0.54 score on a scale
Standard Error 0.423
|
|
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
Week 24
|
-1.03 score on a scale
Standard Error 0.547
|
-2.13 score on a scale
Standard Error 0.591
|
-1.57 score on a scale
Standard Error 0.546
|
-0.68 score on a scale
Standard Error 0.456
|
Adverse Events
HMI-115 60mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
HMI-115 120mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
HMI-115 240mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HMI-115 60mg
n=27 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 participants at risk
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
4.2%
1/24 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
Other adverse events
| Measure |
HMI-115 60mg
n=27 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 120mg
n=27 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
HMI-115 240mg
n=24 participants at risk
Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody
|
Placebo
n=30 participants at risk
Once Every 2 weeks, subcutaneously injection
Placebo: Placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
16.7%
4/24 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
8.3%
2/24 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
10.0%
3/30 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/24 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Asthenia
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/24 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
6.7%
2/30 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
4.2%
1/24 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
10.0%
3/30 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Reproductive system and breast disorders
Amenorrhoea
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
12.5%
3/24 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
4.2%
1/24 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
10.0%
3/30 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
7.4%
2/27 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/24 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.3%
1/30 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
11.1%
3/27 • Number of events 4 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
8.3%
2/24 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.3%
1/30 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Infections and infestations
Vaginal infection
|
7.4%
2/27 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/27 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/24 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
4.2%
1/24 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
13.3%
4/30 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Injection site pruritus
|
3.7%
1/27 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
7.4%
2/27 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
12.5%
3/24 • Number of events 12 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.3%
1/30 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Injection site rash
|
7.4%
2/27 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
11.1%
3/27 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
4.2%
1/24 • Number of events 4 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Injection site reaction
|
3.7%
1/27 • Number of events 5 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
7.4%
2/27 • Number of events 4 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
8.3%
2/24 • Number of events 9 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
0.00%
0/30 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
|
General disorders
Injection site erythema
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.7%
1/27 • Number of events 1 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
8.3%
2/24 • Number of events 3 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
3.3%
1/30 • Number of events 2 • All AEs and SAEs will be collected from the signing of informed consent form until the end of study participation （About 34 weeks）
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 3 months from the time submitted to the sponsor for review. If no response from the sponsor in 3 months, it will be treated as the sponsor agrees the publication.
- Publication restrictions are in place
Restriction type: OTHER