EDELWEISS: A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Sponsor
ObsEva SA (Industry)
Overall Status
Completed
CT.gov ID
NCT02778399
Collaborator
(none)
328
86
6
36
3.8
0.1
Study Details
Study Description
Brief Summary
The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.
Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).
Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
328 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain
Actual Study Start Date
:
Jul 1, 2016
Actual Primary Completion Date
:
Apr 1, 2018
Actual Study Completion Date
:
Jul 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OBE2109 50 mg
|
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
| Experimental: OBE2109 75mg fixed dose (FD)
|
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
| Experimental: OBE2109 75mg titrated dose (TD)
|
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
| Experimental: OBE2109 100mg
|
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
| Experimental: OBE2109 200 mg
|
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
| Placebo Comparator: Placebo / OBE2109 100mg Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. |
Drug: Placebo
Placebo tablets for oral administration once daily
Drug: OBE2109
OBE2109 tablets for oral administration once daily
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS) [From baseline to week 12]
The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
Secondary Outcome Measures
- Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS) [From baseline to week 12]
This endpoint corresponds to the change from baseline to Week 12 in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Numerical Rating Scale (NRS) for pelvic pain of 0 (no pelvic pain) to 10 (worst pelvic pain imaginable). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding [From baseline to week 12]
This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with uterine bleeding/spotting, defined as the mean of daily pain scores on days with uterine bleeding/spotting recorded in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
- Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding [From baseline to week 12]
This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with no uterine bleeding, defined as the mean of daily pain scores on days with no uterine bleeding recorded in electronic diary during the preceding 28 days (4-week period) on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
- Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS) [From baseline to week 12]
This endpoint corresponds to the change from baseline to Week 12 in the mean dyspareunia score, defined as the mean of daily dyspareunia scores recorded in electronic diary during the preceding 28 days (4-week period), assessed on a 0-3 Verbal Rating Scale (VRS) for dyspareunia, with 0 representing "No discomfort during sexual intercourse" and 3 representing "I avoided sexual intercourse because of pain". The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The dyspareunia questionnaire also included an option "not applicable: I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse"; for scoring, answering "not applicable" was considered like a missing value. The relevant time points are Baseline and Week 12.
- Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS) [From baseline to week 12]
This endpoint corresponds to the change from baseline to week 12 in the mean dyschezia score, defined as the mean of weekly dyschezia scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a 0-10 Numerical Rating Scale for dyschezia, with 0 representing no pain and 10 representing the worst pain imaginable. The baseline mean score was calculated as the mean of weekly scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
- Percentage of Subjects With Any Analgesics Use at Week 12 [Up to week 12]
This endpoint corresponds to the percentage of subjects at week 12 who recorded at least one pain medication intake in electronic diary during the preceding 28 days (4-week period).
- Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain [From baseline to week 12]
This endpoint corresponds to the change from baseline to Week 12 in the mean score of pain dimension of the EHP-30. The EHP-30 questionnaire was answered on electronic diary after activation by site staff during subject's monthly visits at site. The EHP-30 pain dimension consists of 11 items each addressing the effect of pain on various activities in the past 4 weeks and each assessed on a 5-point scale (0=Never through to 4=Always). Scaled score was equalled to total of raw score of each item in scale divided by the maximum possible raw score of all the items in the dimension, multiplied by 100, resulting in a score on a scale from 0 (best possible health status) to 100 (worst possible health status). The relevant time points are Baseline and Week 12.
- Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12 [Up to week 12]
The PGIC questionnaire consists of one question rated on a seven point scale (1="Very Much Improved" to 7="Very Much Worse"), with which the subject had to qualify her overall status since the start of the study. The PGIC was answered on electronic diary after activation by site staff during Week 12 visit at site. This endpoint corresponds to the percentage of subjects with an "improvement" in the PGIC score, which includes all subjects who answered "Very much improved" or "Much improved" or "Minimally improved" at Week 12.
- Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12 [Up to week 12]
Subject was asked monthly on electronic diary to assess their impression of endometriosis severity, considering the preceding 4-weeks, with following possible answers: no symptoms, very mild, mild, moderate, severe. This question was programmed to raise automatically every 4 weeks on the subject electronic diary. Result reported here is the percentage of subjects who answered "severe" at week 12.
- Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score [From baseline to week 12]
This endpoint corresponds to the change from baseline to Week 12 in the mean of daily scores for "difficulty in doing daily activities", assessed via electronic diary during the preceding 28 days (4-week period), on a Numerical Rating Scale (NRS) of 0 (no difficulty doing daily activities) to 10 (unable to do daily activities). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.
- Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD) [From baseline up to week 24]
Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE.
- Number of Non Benign Endometrial Biopsies at Week 24 [Week 24]
Any pathological changes in the endometrium at week 24 were assessed from endometrial biopsies. The number of non benign biopsies at Week 24 is presented per treatment arm. Note: an isolated case of hyperplasia (without atypia) was observed at week 12 in the 200 mg group in a subject whose screening biopsy results were normal. A follow-up biopsy at week 24 revealed no abnormalities.
- Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) [From baseline up to week 24]
The endometrium thickness was measured by TVUS at screening and at Week 24 visit by the gynaecologist and result was recorded in mm. This endpoint reports the changes from baseline to Week 24 in the endometrial thickness.
- Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL [From baseline up to week 24]
This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol.
- Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL [From Baseline up to week 24]
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol.
- Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides [From baseline up to week 24]
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
-
The subject has moderate to severe endometriosis-associated pain during the screening period.
-
The subject has regular menstrual cycles.
-
The subject has a BMI ≥ 18 kg/m2 at the screening visit.
Key Exclusion Criteria:
-
The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
-
The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
-
The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
-
The subject has a history of, or known osteoporosis or other metabolic bone disease.
-
The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site reference ID 455 | Chandler | Arizona | United States | |
| 2 | Site reference ID 439 | Scottsdale | Arizona | United States | |
| 3 | Site reference ID 462 | Arcadia | California | United States | |
| 4 | Site reference ID 405 | Chino | California | United States | |
| 5 | Site reference ID 463 | Huntington Park | California | United States | |
| 6 | Site refenrec ID 469 | Northridge | California | United States | |
| 7 | Site reference ID 431 | San Diego | California | United States | |
| 8 | Site reference ID 440 | Tustin | California | United States | |
| 9 | Site reference ID 474 | Denver | Colorado | United States | |
| 10 | Site reference ID 450 | Lakewood | Colorado | United States | |
| 11 | Site reference ID 425 | Longmont | Colorado | United States | |
| 12 | Site reference ID 410 | Washington | District of Columbia | United States | |
| 13 | Site reference ID 457 | Boca Raton | Florida | United States | |
| 14 | Site reference ID 418 | Clearwater | Florida | United States | |
| 15 | Site reference ID 437 | Gainesville | Florida | United States | |
| 16 | Site reference ID 458 | Jensen Beach | Florida | United States | |
| 17 | Site reference ID 420 | Miami Lakes | Florida | United States | |
| 18 | Site reference ID 441 | Miami Springs | Florida | United States | |
| 19 | Site reference ID 411 | Miami | Florida | United States | |
| 20 | Site reference ID 424 | Miami | Florida | United States | |
| 21 | Site reference ID 435 | Miami | Florida | United States | |
| 22 | Site reference ID 423 | New Port Richey | Florida | United States | |
| 23 | Site reference ID 426 | Tampa | Florida | United States | |
| 24 | Site reference ID 442 | Wellington | Florida | United States | |
| 25 | Site reference ID 428 | Atlanta | Georgia | United States | |
| 26 | Site reference ID 459 | Atlanta | Georgia | United States | |
| 27 | Site reference ID 475 | Nampa | Idaho | United States | |
| 28 | Site reference ID 465 | Oak Brook | Illinois | United States | |
| 29 | Site reference ID 404 | Shawnee Mission | Kansas | United States | |
| 30 | Site reference ID 456 | Wichita | Kansas | United States | |
| 31 | Site reference ID 454 | Marrero | Louisiana | United States | |
| 32 | Site reference ID 453 | Metairie | Louisiana | United States | |
| 33 | Site reference ID 478 | Glen Burnie | Maryland | United States | |
| 34 | Site reference ID 445 | Fall River | Massachusetts | United States | |
| 35 | Site reference ID 471 | Fall River | Massachusetts | United States | |
| 36 | Site reference ID 430 | Ann Arbor | Michigan | United States | |
| 37 | Site reference ID 409 | Bay City | Michigan | United States | |
| 38 | Site reference ID 468 | Saginaw | Michigan | United States | |
| 39 | Site reference ID 473 | Saginaw | Michigan | United States | |
| 40 | Site reference ID 427 | Southfield | Michigan | United States | |
| 41 | Site reference ID 421 | Albuquerque | New Mexico | United States | |
| 42 | Site reference ID 466 | New York | New York | United States | |
| 43 | Site reference ID 436 | Greensboro | North Carolina | United States | |
| 44 | Site reference ID 433 | Morehead City | North Carolina | United States | |
| 45 | Site reference ID 443 | Dayton | Ohio | United States | |
| 46 | Site reference ID 472 | Franklin | Ohio | United States | |
| 47 | Site reference ID 415 | Tiffin | Ohio | United States | |
| 48 | Site reference ID 414 | Westerville | Ohio | United States | |
| 49 | Site reference ID 419 | Bryn Mawr | Pennsylvania | United States | |
| 50 | Site reference ID 449 | Jenkintown | Pennsylvania | United States | |
| 51 | Site reference ID 476 | Columbia | South Carolina | United States | |
| 52 | Site reference ID 408 | Bristol | Tennessee | United States | |
| 53 | Site reference ID 403 | Chattanooga | Tennessee | United States | |
| 54 | Site reference ID 429 | Nashville | Tennessee | United States | |
| 55 | Site reference ID 452 | Austin | Texas | United States | |
| 56 | Site reference ID 461 | Beaumont | Texas | United States | |
| 57 | Site reference ID 447 | Dallas | Texas | United States | |
| 58 | Site reference ID 460 | Dallas | Texas | United States | |
| 59 | Site reference ID 464 | Fort Worth | Texas | United States | |
| 60 | Site reference ID 413 | Houston | Texas | United States | |
| 61 | Site reference ID 434 | Houston | Texas | United States | |
| 62 | Site reference ID 479 | Houston | Texas | United States | |
| 63 | Site reference ID 451 | San Antonio | Texas | United States | |
| 64 | Site reference ID 402 | Schertz | Texas | United States | |
| 65 | Site reference ID 432 | Webster | Texas | United States | |
| 66 | Site reference ID 422 | Draper | Utah | United States | |
| 67 | Site reference ID 467 | Centreville | Virginia | United States | |
| 68 | Site reference ID 407 | Norfolk | Virginia | United States | |
| 69 | Site reference ID 412 | Richmond | Virginia | United States | |
| 70 | Site reference ID 417 | Richmond | Virginia | United States | |
| 71 | Site reference ID 406 | Seattle | Washington | United States | |
| 72 | Site reference ID 101 | Katowice | Poland | ||
| 73 | Site reference ID 102 | Katowice | Poland | ||
| 74 | Site reference ID 104 | Lublin | Poland | ||
| 75 | Site reference ID 105 | Lublin | Poland | ||
| 76 | Site reference ID 103 | Szczecin | Poland | ||
| 77 | Site reference ID 201 | Moscow | Russian Federation | ||
| 78 | Site reference ID 202 | Moscow | Russian Federation | ||
| 79 | Site reference ID 203 | Moscow | Russian Federation | ||
| 80 | Site reference ID 204 | Moscow | Russian Federation | ||
| 81 | Site reference ID 205 | Saint Petersburg | Russian Federation | ||
| 82 | Site reference ID 305 | Ivano-Frankivs'k | Ukraine | ||
| 83 | Site reefrence ID 303 | Kyiv | Ukraine | ||
| 84 | Site reference ID 301 | Kyiv | Ukraine | ||
| 85 | Site reference ID 302 | Kyiv | Ukraine | ||
| 86 | SIte reference ID 304 | Kyiv | Ukraine |
Sponsors and Collaborators
- ObsEva SA
Investigators
- Study Director: ObsEva SA, Geneva
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
ObsEva SA
ClinicalTrials.gov Identifier:
NCT02778399
Other Study ID Numbers:
- 15-OBE2109-001
First Posted:
May 19, 2016
Last Update Posted:
Jul 21, 2022
Last Verified:
Jun 1, 2022
Keywords provided by ObsEva SA
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 328 females were randomized at 62 sites in 4 countries: 48 sites in USA (177 subjects), 5 sites in Poland (67 subjects), 5 sites in Ukraine (73 subjects) and 4 sites in Russia (11 subjects). |
|---|---|
| Pre-assignment Detail | 716 subjects were screened and 328 were randomized; 327 were included in the safety set (1 not included as didn't receive study treatment). 323 subjects were included in the Full Analysis Set (FAS), 5 randomized subjects were excluded: 1 as per the safety set and 4 were prematurely discontinued at one US site due to the site's serious non-compliance to the protocol. |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily. FD = Fixed Dose | OBE2109 tablets for oral administration once daily. TD = Titrated Dose | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Period Title: Up to Week 12 Treatment Period | ||||||
| STARTED | 54 | 49 | 57 | 58 | 53 | 57 |
| Included in SAFETY SET | 54 | 49 | 57 | 58 | 52 | 57 |
| Included in FAS | 53 | 49 | 56 | 58 | 51 | 56 |
| COMPLETED | 45 | 45 | 53 | 51 | 45 | 49 |
| NOT COMPLETED | 9 | 4 | 4 | 7 | 8 | 8 |
| Period Title: Up to Week 12 Treatment Period | ||||||
| STARTED | 45 | 45 | 53 | 51 | 45 | 49 |
| COMPLETED | 37 | 41 | 48 | 46 | 39 | 42 |
| NOT COMPLETED | 8 | 4 | 5 | 5 | 6 | 7 |
Baseline Characteristics
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | Total of all reporting groups |
| Overall Participants | 53 | 49 | 56 | 58 | 51 | 56 | 323 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
53
100%
|
49
100%
|
56
100%
|
58
100%
|
51
100%
|
56
100%
|
323
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
32.4
(5.78)
|
30.9
(5.98)
|
32.0
(6.83)
|
31.2
(5.85)
|
33.0
(5.78)
|
30.9
(6.03)
|
31.7
(6.06)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
53
100%
|
49
100%
|
56
100%
|
58
100%
|
51
100%
|
56
100%
|
323
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
3
5.7%
|
5
10.2%
|
3
5.4%
|
7
12.1%
|
4
7.8%
|
5
8.9%
|
27
8.4%
|
| Not Hispanic or Latino |
25
47.2%
|
18
36.7%
|
27
48.2%
|
25
43.1%
|
24
47.1%
|
23
41.1%
|
142
44%
|
| Unknown or Not Reported |
25
47.2%
|
26
53.1%
|
26
46.4%
|
26
44.8%
|
23
45.1%
|
28
50%
|
154
47.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
7.5%
|
2
4.1%
|
5
8.9%
|
8
13.8%
|
3
5.9%
|
3
5.4%
|
25
7.7%
|
| White |
49
92.5%
|
46
93.9%
|
50
89.3%
|
50
86.2%
|
46
90.2%
|
52
92.9%
|
293
90.7%
|
| More than one race |
0
0%
|
1
2%
|
1
1.8%
|
0
0%
|
2
3.9%
|
1
1.8%
|
5
1.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS) |
|---|---|
| Description | The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Number [percentage of subjects] |
34.5
|
49.4
|
61.5
|
56.4
|
56.3
|
| Title | Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS) |
|---|---|
| Description | This endpoint corresponds to the change from baseline to Week 12 in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Numerical Rating Scale (NRS) for pelvic pain of 0 (no pelvic pain) to 10 (worst pelvic pain imaginable). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Mean (95% Confidence Interval) [score on a scale] |
-1.17
|
-1.75
|
-2.15
|
-2.06
|
-2.14
|
| Title | Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding |
|---|---|
| Description | This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with uterine bleeding/spotting, defined as the mean of daily pain scores on days with uterine bleeding/spotting recorded in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Number [percentage of subjects] |
28.5
|
43.3
|
68.2
|
68.6
|
78.9
|
| Title | Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding |
|---|---|
| Description | This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with no uterine bleeding, defined as the mean of daily pain scores on days with no uterine bleeding recorded in electronic diary during the preceding 28 days (4-week period) on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 50 | 55 |
| Number [percentage of subjects] |
37.1
|
46.2
|
58.5
|
61.5
|
47.7
|
| Title | Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS) |
|---|---|
| Description | This endpoint corresponds to the change from baseline to Week 12 in the mean dyspareunia score, defined as the mean of daily dyspareunia scores recorded in electronic diary during the preceding 28 days (4-week period), assessed on a 0-3 Verbal Rating Scale (VRS) for dyspareunia, with 0 representing "No discomfort during sexual intercourse" and 3 representing "I avoided sexual intercourse because of pain". The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The dyspareunia questionnaire also included an option "not applicable: I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse"; for scoring, answering "not applicable" was considered like a missing value. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 47 | 40 | 90 | 44 | 44 |
| Mean (95% Confidence Interval) [score on a scale] |
-0.39
|
-0.62
|
-0.59
|
-0.66
|
-0.79
|
| Title | Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS) |
|---|---|
| Description | This endpoint corresponds to the change from baseline to week 12 in the mean dyschezia score, defined as the mean of weekly dyschezia scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a 0-10 Numerical Rating Scale for dyschezia, with 0 representing no pain and 10 representing the worst pain imaginable. The baseline mean score was calculated as the mean of weekly scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 113 | 50 | 55 |
| Mean (95% Confidence Interval) [score on a scale/week] |
-0.78
|
-1.55
|
-1.87
|
-1.97
|
-1.7
|
| Title | Percentage of Subjects With Any Analgesics Use at Week 12 |
|---|---|
| Description | This endpoint corresponds to the percentage of subjects at week 12 who recorded at least one pain medication intake in electronic diary during the preceding 28 days (4-week period). |
| Time Frame | Up to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Number (95% Confidence Interval) [percentage of subjects] |
90.6
|
77.1
|
74.8
|
68.8
|
72.1
|
| Title | Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain |
|---|---|
| Description | This endpoint corresponds to the change from baseline to Week 12 in the mean score of pain dimension of the EHP-30. The EHP-30 questionnaire was answered on electronic diary after activation by site staff during subject's monthly visits at site. The EHP-30 pain dimension consists of 11 items each addressing the effect of pain on various activities in the past 4 weeks and each assessed on a 5-point scale (0=Never through to 4=Always). Scaled score was equalled to total of raw score of each item in scale divided by the maximum possible raw score of all the items in the dimension, multiplied by 100, resulting in a score on a scale from 0 (best possible health status) to 100 (worst possible health status). The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 41 | 41 | 96 | 43 | 44 |
| Mean (95% Confidence Interval) [score on a scale] |
-7.4
|
-18.5
|
-18.9
|
-19.4
|
-20.9
|
| Title | Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12 |
|---|---|
| Description | The PGIC questionnaire consists of one question rated on a seven point scale (1="Very Much Improved" to 7="Very Much Worse"), with which the subject had to qualify her overall status since the start of the study. The PGIC was answered on electronic diary after activation by site staff during Week 12 visit at site. This endpoint corresponds to the percentage of subjects with an "improvement" in the PGIC score, which includes all subjects who answered "Very much improved" or "Much improved" or "Minimally improved" at Week 12. |
| Time Frame | Up to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 43 | 42 | 98 | 43 | 46 |
| Number [percentage of subjects] |
65.1
|
78.6
|
80.6
|
86
|
95.7
|
| Title | Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12 |
|---|---|
| Description | Subject was asked monthly on electronic diary to assess their impression of endometriosis severity, considering the preceding 4-weeks, with following possible answers: no symptoms, very mild, mild, moderate, severe. This question was programmed to raise automatically every 4 weeks on the subject electronic diary. Result reported here is the percentage of subjects who answered "severe" at week 12. |
| Time Frame | Up to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Number [percentage of subjects] |
20.9
|
4.5
|
7.8
|
4.5
|
4.2
|
| Title | Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score |
|---|---|
| Description | This endpoint corresponds to the change from baseline to Week 12 in the mean of daily scores for "difficulty in doing daily activities", assessed via electronic diary during the preceding 28 days (4-week period), on a Numerical Rating Scale (NRS) of 0 (no difficulty doing daily activities) to 10 (unable to do daily activities). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12. |
| Time Frame | From baseline to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD + TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 52 | 48 | 114 | 51 | 55 |
| Mean (95% Confidence Interval) [score on a scale] |
-1.17
|
-1.65
|
-2.06
|
-1.88
|
-1.99
|
| Title | Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD) |
|---|---|
| Description | Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE. |
| Time Frame | From baseline up to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available BMD results at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 34 | 38 | 45 | 42 | 37 | 38 |
| Mean (95% Confidence Interval) [percentage change] |
-0.929
|
0.137
|
-0.798
|
-1.000
|
-1.365
|
-2.602
|
| Title | Number of Non Benign Endometrial Biopsies at Week 24 |
|---|---|
| Description | Any pathological changes in the endometrium at week 24 were assessed from endometrial biopsies. The number of non benign biopsies at Week 24 is presented per treatment arm. Note: an isolated case of hyperplasia (without atypia) was observed at week 12 in the 200 mg group in a subject whose screening biopsy results were normal. A follow-up biopsy at week 24 revealed no abnormalities. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available endometrial biopsy result at Week 24 in the respective group (excluding those with tissue unsatisfactory for evaluation), from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks. | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 11 | 16 | 19 | 17 | 13 | 4 |
| Number [Non benign biopsies] |
0
|
0
|
0
|
0
|
0
|
0
|
| Title | Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) |
|---|---|
| Description | The endometrium thickness was measured by TVUS at screening and at Week 24 visit by the gynaecologist and result was recorded in mm. This endpoint reports the changes from baseline to Week 24 in the endometrial thickness. |
| Time Frame | From baseline up to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available TVUS result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 35 | 41 | 49 | 45 | 39 | 41 |
| Mean (Standard Deviation) [mm] |
-3.1
(4.64)
|
-1.5
(4.28)
|
-2.3
(4.15)
|
-1.3
(3.70)
|
-1.6
(4.56)
|
-4.0
(3.39)
|
| Title | Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL |
|---|---|
| Description | This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol. |
| Time Frame | From baseline up to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available laboratory LDL result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 39 | 40 | 48 | 47 | 41 | 41 |
| Mean (Standard Deviation) [percent change] |
1.7
(15.7)
|
-0.3
(16.6)
|
7.4
(55.2)
|
7.3
(21.4)
|
9.7
(20.7)
|
10.3
(21.7)
|
| Title | Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL |
|---|---|
| Description | This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol. |
| Time Frame | From Baseline up to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available laboratory HDL result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 39 | 40 | 48 | 47 | 41 | 41 |
| Mean (Standard Deviation) [percent change] |
5.5
(11.7)
|
2.9
(12.9)
|
3.8
(17.8)
|
6.2
(24.1)
|
5.6
(18.0)
|
8.1
(14.7)
|
| Title | Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides |
|---|---|
| Description | This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides. |
| Time Frame | From baseline up to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with available laboratory result for Triglycerides at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received). |
| Arm/Group Title | Placebo / OBE2109 100mg | OBE2109 50mg | OBE2109 75mg FD | OBE2109 75mg TD | OBE2109 100mg | OBE2109 200mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily | OBE2109 tablets for oral administration once daily |
| Measure Participants | 39 | 40 | 48 | 47 | 41 | 41 |
| Mean (Standard Deviation) [percent change] |
17.9
(38.6)
|
16.4
(41.3)
|
5.2
(35.2)
|
13.6
(45.0)
|
20.5
(80.6)
|
24.0
(57.7)
|
Adverse Events
| Time Frame | From baseline up to week 24 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Placebo BL-Wk12 | OBE2109 100mg Wk12-Wk24 | OBE2109 50mg BL-Wk24 | OBE2109 75mg FD BL-Wk24 | OBE2109 75mg TD BL-Wk24 | OBE2109 100mg BL-Wk24 | OBE2109 200mg BL-Wk24 | |||||||
| Arm/Group Description | Placebo: Placebo tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks, from baseline (BL) to week 12 (Wk12). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks (from week 12 to week 24, reported in separate group). | OBE2109: OBE2109 tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks from baseline to week 12 (reported in separate group). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks, from week 12 (Wk12) to week 24 (Wk24). | OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24) | OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24) | OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24) | OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24) | OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24) | |||||||
All Cause Mortality |
||||||||||||||
| Placebo BL-Wk12 | OBE2109 100mg Wk12-Wk24 | OBE2109 50mg BL-Wk24 | OBE2109 75mg FD BL-Wk24 | OBE2109 75mg TD BL-Wk24 | OBE2109 100mg BL-Wk24 | OBE2109 200mg BL-Wk24 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/55 (0%) | 0/49 (0%) | 0/58 (0%) | 0/56 (0%) | 0/52 (0%) | 0/57 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo BL-Wk12 | OBE2109 100mg Wk12-Wk24 | OBE2109 50mg BL-Wk24 | OBE2109 75mg FD BL-Wk24 | OBE2109 75mg TD BL-Wk24 | OBE2109 100mg BL-Wk24 | OBE2109 200mg BL-Wk24 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/55 (1.8%) | 0/55 (0%) | 1/49 (2%) | 0/58 (0%) | 0/56 (0%) | 3/52 (5.8%) | 1/57 (1.8%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Enterocolitis | 0/55 (0%) | 0/55 (0%) | 0 | 0/49 (0%) | 0 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 1/52 (1.9%) | 1 | 0/57 (0%) | 0 | |
| Infections and infestations | ||||||||||||||
| Pyelonephritis acute | 0/55 (0%) | 0/55 (0%) | 0 | 1/49 (2%) | 1 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 0/52 (0%) | 0 | 0/57 (0%) | 0 | |
| Injury, poisoning and procedural complications | ||||||||||||||
| Stab wound | 1/55 (1.8%) | 0/55 (0%) | 0/49 (0%) | 0 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 0/52 (0%) | 0 | 0/57 (0%) | 0 | ||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||
| Ectopic pregnancy | 0/55 (0%) | 0/55 (0%) | 0 | 0/49 (0%) | 0 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 1/52 (1.9%) | 1 | 0/57 (0%) | 0 | |
| Reproductive system and breast disorders | ||||||||||||||
| Metrorrhagia | 0/55 (0%) | 0/55 (0%) | 0 | 0/49 (0%) | 0 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 1/52 (1.9%) | 1 | 0/57 (0%) | 0 | |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Pulmonary Embolism | 0/55 (0%) | 0/55 (0%) | 0 | 0/49 (0%) | 0 | 0/58 (0%) | 0 | 0/56 (0%) | 0 | 0/52 (0%) | 0 | 1/57 (1.8%) | 1 | |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo BL-Wk12 | OBE2109 100mg Wk12-Wk24 | OBE2109 50mg BL-Wk24 | OBE2109 75mg FD BL-Wk24 | OBE2109 75mg TD BL-Wk24 | OBE2109 100mg BL-Wk24 | OBE2109 200mg BL-Wk24 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/55 (40%) | 19/55 (34.5%) | 27/49 (55.1%) | 30/58 (51.7%) | 36/56 (64.3%) | 31/52 (59.6%) | 39/57 (68.4%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| abdominal pain upper | 1/55 (1.8%) | 2/55 (3.6%) | 1/49 (2%) | 0/58 (0%) | 1/56 (1.8%) | 4/52 (7.7%) | 1/57 (1.8%) | |||||||
| nausea | 1/55 (1.8%) | 0/55 (0%) | 3/49 (6.1%) | 2/58 (3.4%) | 2/56 (3.6%) | 4/52 (7.7%) | 7/57 (12.3%) | |||||||
| toothache | 3/55 (5.5%) | 1/55 (1.8%) | 3/49 (6.1%) | 2/58 (3.4%) | 0/56 (0%) | 0/52 (0%) | 1/57 (1.8%) | |||||||
| General disorders | ||||||||||||||
| fatigue | 0/55 (0%) | 0/55 (0%) | 1/49 (2%) | 0/58 (0%) | 0/56 (0%) | 4/52 (7.7%) | 2/57 (3.5%) | |||||||
| pyrexia | 0/55 (0%) | 0/55 (0%) | 2/49 (4.1%) | 0/58 (0%) | 1/56 (1.8%) | 1/52 (1.9%) | 3/57 (5.3%) | |||||||
| Infections and infestations | ||||||||||||||
| bronchitis | 0/55 (0%) | 0/55 (0%) | 0/49 (0%) | 2/58 (3.4%) | 0/56 (0%) | 1/52 (1.9%) | 3/57 (5.3%) | |||||||
| influenza | 0/55 (0%) | 1/55 (1.8%) | 1/49 (2%) | 0/58 (0%) | 0/56 (0%) | 3/52 (5.8%) | 0/57 (0%) | |||||||
| nasopharyngitis | 3/55 (5.5%) | 1/55 (1.8%) | 8/49 (16.3%) | 7/58 (12.1%) | 4/56 (7.1%) | 2/52 (3.8%) | 1/57 (1.8%) | |||||||
| urinary tract infection | 0/55 (0%) | 0/55 (0%) | 1/49 (2%) | 3/58 (5.2%) | 3/56 (5.4%) | 2/52 (3.8%) | 5/57 (8.8%) | |||||||
| Investigations | ||||||||||||||
| blood creatine phosphokinase increased | 1/55 (1.8%) | 1/55 (1.8%) | 1/49 (2%) | 4/58 (6.9%) | 5/56 (8.9%) | 2/52 (3.8%) | 4/57 (7%) | |||||||
| weight increased | 0/55 (0%) | 1/55 (1.8%) | 2/49 (4.1%) | 0/58 (0%) | 1/56 (1.8%) | 3/52 (5.8%) | 1/57 (1.8%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| arthralgia | 0/55 (0%) | 0/55 (0%) | 1/49 (2%) | 0/58 (0%) | 1/56 (1.8%) | 3/52 (5.8%) | 9/57 (15.8%) | |||||||
| back pain | 0/55 (0%) | 1/55 (1.8%) | 3/49 (6.1%) | 0/58 (0%) | 2/56 (3.6%) | 0/52 (0%) | 0/57 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| dizziness | 0/55 (0%) | 0/55 (0%) | 1/49 (2%) | 3/58 (5.2%) | 1/56 (1.8%) | 2/52 (3.8%) | 2/57 (3.5%) | |||||||
| headache | 14/55 (25.5%) | 9/55 (16.4%) | 12/49 (24.5%) | 10/58 (17.2%) | 16/56 (28.6%) | 15/52 (28.8%) | 17/57 (29.8%) | |||||||
| Psychiatric disorders | ||||||||||||||
| libido decreased | 0/55 (0%) | 1/55 (1.8%) | 0/49 (0%) | 1/58 (1.7%) | 0/56 (0%) | 0/52 (0%) | 3/57 (5.3%) | |||||||
| mood swings | 5/55 (9.1%) | 1/55 (1.8%) | 2/49 (4.1%) | 1/58 (1.7%) | 3/56 (5.4%) | 3/52 (5.8%) | 2/57 (3.5%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| vulvovaginal dryness | 0/55 (0%) | 0/55 (0%) | 0/49 (0%) | 0/58 (0%) | 1/56 (1.8%) | 2/52 (3.8%) | 3/57 (5.3%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| acne | 1/55 (1.8%) | 0/55 (0%) | 2/49 (4.1%) | 3/58 (5.2%) | 2/56 (3.6%) | 0/52 (0%) | 1/57 (1.8%) | |||||||
| Vascular disorders | ||||||||||||||
| hot flush | 6/55 (10.9%) | 5/55 (9.1%) | 9/49 (18.4%) | 11/58 (19%) | 13/56 (23.2%) | 15/52 (28.8%) | 26/57 (45.6%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PI cannot disclose study information which is not publicly available without prior written consent of Sponsor.
Results Point of Contact
| Name/Title | Medical Responsible |
|---|---|
| Organization | Clinical Operations |
| Phone | +41 (0)22 552 1560 |
| clinicaltrials@obseva.ch |
Responsible Party:
ObsEva SA
ClinicalTrials.gov Identifier:
NCT02778399
Other Study ID Numbers:
- 15-OBE2109-001
First Posted:
May 19, 2016
Last Update Posted:
Jul 21, 2022
Last Verified:
Jun 1, 2022