Trial Outcomes & Findings for BGS649 Monotherapy in Moderate to Severe Endometriosis Patients (NCT NCT01190475)

Results Overview

Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

8 months

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	BGS649 High Dose 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules	BGS649 Low Dose 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules	Placebo 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Overall Study STARTED	2	2	2
Overall Study COMPLETED	2	2	1
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BGS649 High Dose 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules	BGS649 Low Dose 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules	Placebo 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGS649 High Dose n=2 Participants 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules	BGS649 Low Dose n=2 Participants 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules	Placebo n=2 Participants 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30 years n=5 Participants	28 years n=7 Participants	30.5 years n=5 Participants	29 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 months

Population: Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger

Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.

Outcome measures

Outcome measures
Measure	BGS649 High Dose n=2 Participants BGS649	BGS649 Low Dose n=2 Participants BGS649	Placebo n=2 Participants Placebo
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 hours

Population: Full analysis set

AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

Outcome measures

Outcome measures
Measure	BGS649 High Dose n=2 Participants BGS649	BGS649 Low Dose n=2 Participants BGS649	Placebo Placebo
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h AUC0-672 at Cycle 4	3283 ng*hr/mL Interval 2960.0 to 3610.0	639.6 ng*hr/mL Interval 639.6 to 639.6	—
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h AUC0-672 at Cycle 2	2557 ng*hr/mL Interval 2430.0 to 2690.0	443.8 ng*hr/mL Interval 443.8 to 443.8	—

SECONDARY outcome

Timeframe: 8 hours

Population: Pharmacokinetic patient population. Study met the pre-defined safety stopping criteria and so was not fully enrolled. The PK results of for one of the patients could not be reported - missing data for cycle 2 and meeting the stopping criteria before cycle 4.

The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

Outcome measures

Outcome measures
Measure	BGS649 High Dose n=2 Participants BGS649	BGS649 Low Dose n=1 Participants BGS649	Placebo Placebo
Pharmacokinetic Profile of BGS649 as Described by Cmax Cycle 2	9.040 ng/mL Standard Deviation 4.0447	2.720 ng/mL	—
Pharmacokinetic Profile of BGS649 as Described by Cmax Cycle 4	15.25 ng/mL Standard Deviation 0.91924	3.410 ng/mL	—

SECONDARY outcome

Timeframe: 8 hours

Population: Pharmacokinetic patient population. Study met the pre-defined safety stopping criteria and so was not fully enrolled. The PK results of for one of the patients could not be reported - missing data for cycle 2 and meeting the stopping criteria before cycle 4.

Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.

Outcome measures

Outcome measures
Measure	BGS649 High Dose n=2 Participants BGS649	BGS649 Low Dose n=1 Participants BGS649	Placebo Placebo
Pharmacokinetic Profile of BGS649 as Described by Tmax Cycle 2	1.00 hours Interval 1.0 to 1.0	1.00 hours Interval 1.0 to 1.0	—
Pharmacokinetic Profile of BGS649 as Described by Tmax Cycle 4	1.00 hours Interval 1.0 to 1.0	1.00 hours Interval 1.0 to 1.0	—

Adverse Events

BGS649 High Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BGS649 Low Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BGS649 High Dose n=2 participants at risk 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.	BGS649 Low Dose n=2 participants at risk 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules	Placebo n=2 participants at risk 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Gastrointestinal disorders Abdominal pain	0.00% 0/2	50.0% 1/2 • Number of events 1	0.00% 0/2
Skin and subcutaneous tissue disorders Acne	0.00% 0/2	0.00% 0/2	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/2	0.00% 0/2	50.0% 1/2 • Number of events 1
Nervous system disorders Headache	0.00% 0/2	0.00% 0/2	50.0% 1/2 • Number of events 1
Reproductive system and breast disorders Menorrhagia	0.00% 0/2	50.0% 1/2 • Number of events 1	0.00% 0/2
Reproductive system and breast disorders Metrorrhagia	50.0% 1/2 • Number of events 1	0.00% 0/2	0.00% 0/2
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1	0.00% 0/2	0.00% 0/2
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	50.0% 1/2 • Number of events 1	0.00% 0/2	0.00% 0/2

Additional Information

Jacqueline Parkin

Mereo BioPharma

Phone: +44 333 0237300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor prior to publication of any trial results.
Publication restrictions are in place

Restriction type: OTHER