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Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

Sponsor
Arthrosi Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05119686
Collaborator
(none)
120
Enrollment
23
Locations
3
Arms
10.5
Anticipated Duration (Months)
5.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.

Condition or Disease Intervention/Treatment Phase
  • Drug: AR882 Dose 1
  • Drug: AR882 Dose 2
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

AR882 Dose 1 x 12 weeks

Drug: AR882 Dose 1
Solid Oral Capsule
Experimental: Group 2

AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks

Drug: AR882 Dose 1
Solid Oral Capsule

Drug: AR882 Dose 2
Solid Oral Capsule
Placebo Comparator: Group 3

AR882 matching placebo x 12 weeks

Drug: Placebo
Matching Solid Oral Capsule Placebo

Outcome Measures

Primary Outcome Measures

  1. Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing [6 weeks]

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing

Secondary Outcome Measures

  1. sUA levels < 5, < 4, and < 3 mg/dL [6 weeks]

    Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL

  2. Incidence of Adverse Events [14 weeks]

    Treatment Emergent Adverse Events and Serious Adverse Event incidence.

  3. Maximum Observed Plasma Concentration (Cmax) [12 weeks]

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.

  4. Time to observed Cmax (Tmax) [12 weeks]

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.

  5. Area under the plasma concentration-time curve (AUC) [12 weeks]

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • History of gout

  • sUA > 7 mg/dL

  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin

  • History of cardiac abnormalities

  • History of kidney stones

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arthrosi Investigative Site Gilbert Arizona United States 85297
2 Arthrosi Investigative Site Sun City Arizona United States 85351
3 Arthrosi Investigative Site Tucson Arizona United States 85704
4 Arthrosi Investigative Site Miami Lakes Florida United States 33014
5 Arthrosi Investigative Site Miami Florida United States 33143
6 Arthrosi Investigative Site Tampa Florida United States 33613
7 Arthrosi Investigative Site Honolulu Hawaii United States 96814
8 Arthrosi Investigative Site Overland Park Kansas United States 66212
9 Arthrosi Investigative Site Cleveland Ohio United States 44122
10 Arthrosi Investigative Site Cleveland Ohio United States 44195
11 Arthrosi Investigative Site Duncansville Pennsylvania United States 16635
12 Arthrosi Investigative Site Dallas Texas United States 75231
13 Arthrosi Investigative Site Houston Texas United States 77074
14 Arthrosi Investigative Site Tomball Texas United States 77375
15 Arthrosi Investigative Site West Jordan Utah United States 84088
16 Arthrosi Investigative Site Glendale Wisconsin United States 53217
17 Arthrosi Investigative Site Melbourne Camberwell Australia 3124
18 Arthrosi investigative Site Botany New South Wales Australia 2019
19 Arthrosi Investigative Site Taichung City Taiwan 402
20 Arthrosi Investigative Site - 301 Taipei City Taiwan 112
21 Arthrosi Investigative Site - 304 Taipei City Taiwan 112
22 Arthrosi Investigative Site Taipei City Taiwan 114
23 Arthrosi Investigative Site Taoyuan Taiwan 333

Sponsors and Collaborators

  • Arthrosi Therapeutics

Investigators

  • Study Chair: R Keenan, MD, Arthrosi Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arthrosi Therapeutics
ClinicalTrials.gov Identifier:
NCT05119686
Other Study ID Numbers:
  • AR882-202
First Posted:
Nov 15, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gout
Arthritis, Gouty
Hyperuricemia

Study Results

No Results Posted as of Jul 19, 2022