A Proof-of-Concept Study of AC-201 to Prevent Gout Flares

NCT01712204 | Completed Phase 2 Results

• 1 other identifier: AC-201-GOU-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis with good safety record and very few contraindications to the co-morbidities commonly among gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in clinical trials. The favorable product profile of AC-201 overall provides a strong rationale for investigating its clinical utility as prophylaxis against flares when initiating ULT.

Conditions

Gout Flares

Keywords

Prophylaxis of Acute Gout Flares; Urate-Lowering Therapy; Hyperuricemia; Gouty arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Gout Flares Per Subject

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo plus Febuxostat

Drug: Placebo; Drug: Febuxostat

AC-201

EXPERIMENTAL

AC-201 plus Febuxostat

Drug: AC-201; Drug: Febuxostat

Interventions

Placebo DRUG

Placebo Capsule BID for 16 Weeks

Also known as: PBO

Placebo

AC-201 DRUG

AC-201 50mg Capsule BID for 16 Weeks

AC-201

Febuxostat DRUG

Febuxostat 80 mg QD for 16 Weeks

Also known as: ULT

AC-201; Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 20 to 80 years, inclusive
• Meets at least 6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout, OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid
• Serum uric acid ≥7.5 mg/dL at screening
• Experienced ≥2 gouty arthritis flares within one year prior to screening

You may not qualify if:

• Occurrence of a gouty arthritis flare ongoing at screening or during the screening period through baseline
• Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4 weeks prior to screening
• Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to screening
• Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases with arthritis, or any condition requiring chronic daily use of pain medication
• History of allergy to any components of study medication, including diacerein
• Allergy, contraindication, or intolerance to febuxostat
• Contraindication or allergy to NSAIDs
• Severe renal impairment
• Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator

Sponsors & Collaborators

• TWi Biotechnology, Inc.: lead

Study Sites (1)

Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hyperuricemia; Arthritis, Gouty

Interventions

diacerein; Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: TWi Biotechnology, Inc.

Carl.Brown@twipharma.com

+886-2-26573350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 22, 2018
• Results First Posted: December 1, 2014

Record last verified: 2018-04

Locations

TW (1)