Trial Outcomes & Findings for Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients (NCT NCT01399008)

Results Overview

Percent change from baseline in serum uric acid in Per Protocol population

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Percent change from baseline in serum uric acid at Week 4

Results posted on

2015-09-18

Participant Flow

Upon completion of screening all patients will enter into a 3-week run-in/stabilization period starting at Week -3 (Visit 1). During this phase, all patients will take allopurinol 300 mg once daily. In addition, patients will be given colchicine 0.6 mg once daily until the final study visit as prophylaxis to prevent potential gout flares.

Participant milestones

Participant milestones
Measure	Arhalofenate 400 mg Arhalofenate 400 mg plus allopurinol 300 mg	Arhalofenate 600 mg Arhalofenate 600 mg plus allopurinol 300 mg	Placebo Placebo plus Allopurinol 300 mg
Overall Study STARTED	35	32	33
Overall Study COMPLETED	32	27	31
Overall Study NOT COMPLETED	3	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arhalofenate 400 mg n=35 Participants Arhalofenate 400 mg plus allopurinol 300 mg	Arhalofenate 600 mg n=32 Participants Arhalofenate 600 mg plus allopurinol 300 mg	Placebo n=33 Participants Placebo plus Allopurinol 300 mg	Total n=100 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 10.9 • n=5 Participants	50.6 years STANDARD_DEVIATION 10.2 • n=7 Participants	50.4 years STANDARD_DEVIATION 11.0 • n=5 Participants	51.4 years STANDARD_DEVIATION 10.6 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	99 Participants n=4 Participants

PRIMARY outcome

Timeframe: Percent change from baseline in serum uric acid at Week 4

Population: Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).

Percent change from baseline in serum uric acid in Per Protocol population

Outcome measures

Outcome measures
Measure	Arhalofenate 400 mg n=34 Participants Arhalofenate 400 mg plus allopurinol 300 mg	Arhalofenate 600 mg n=30 Participants Arhalofenate 600 mg plus allopurinol 300 mg	Placebo n=31 Participants Placebo plus Allopurinol 300 mg
Serum Uric Acid	-16.0 percent change Standard Deviation 20.9	-9.9 percent change Standard Deviation 17.1	-9.5 percent change Standard Deviation 19.0

Adverse Events

Arhalofenate 400 mg Plus Allopurinol 300 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Arhalofenate 600 mg Plus Allopurinol 300 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Plus Allopurinol 300 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arhalofenate 400 mg Plus Allopurinol 300 mg n=35 participants at risk Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)	Arhalofenate 600 mg Plus Allopurinol 300 mg n=32 participants at risk Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)	Placebo Plus Allopurinol 300 mg n=33 participants at risk Placebo plus allopurinol 300 mg (Safety Population)
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/35 • 6 weeks (Treatment/Post Treatment Periods)	6.2% 2/32 • 6 weeks (Treatment/Post Treatment Periods)	0.00% 0/33 • 6 weeks (Treatment/Post Treatment Periods)
Nervous system disorders Headache	2.9% 1/35 • 6 weeks (Treatment/Post Treatment Periods)	6.2% 2/32 • 6 weeks (Treatment/Post Treatment Periods)	3.0% 1/33 • 6 weeks (Treatment/Post Treatment Periods)
Infections and infestations Upper respiratory tract infection	0.00% 0/35 • 6 weeks (Treatment/Post Treatment Periods)	0.00% 0/32 • 6 weeks (Treatment/Post Treatment Periods)	6.1% 2/33 • 6 weeks (Treatment/Post Treatment Periods)
Renal and urinary disorders Gout flare	28.6% 10/35 • 6 weeks (Treatment/Post Treatment Periods)	6.2% 2/32 • 6 weeks (Treatment/Post Treatment Periods)	27.3% 9/33 • 6 weeks (Treatment/Post Treatment Periods)

Additional Information

Mary Jean Stempien, M.D., Acting Chief Medical Officer

Metabolex

Phone: 510-293-8800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication requires the prior written consent of the Sponsor. The Principal Investigator must provide the Sponsor the opportunity to review any proposed abstracts, manuscripts or presentations that relate to any research or clinical results at least 30 days prior to its intended submission for publication.
Publication restrictions are in place

Restriction type: OTHER