A Phase 2 interventional study of Placebo and AC-201 in Gout, sponsored by TWi Biotechnology, Inc.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-28.
Sponsored by TWi Biotechnology, Inc. · Phase 2, Interventional, and Treatment
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism of action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's enrollment of 127 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →TWi Biotechnology, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo plus Febuxostat
Drug: Placebo · Drug: Febuxostat
AC-201 CR tablet plus Febuxostat
Drug: AC-201 · Drug: Febuxostat
Placebo twice daily from Day 1 to Week 12
Also known as: PBO
AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Also known as: AC-201 CR tablet
Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL
Also known as: ULT
Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL
Time frame: 8 weeks
| Milestone | Placebo | AC-201 |
|---|---|---|
| Started | 60 | 67 |
| Completed | 53 | 54 |
| Not completed | 7 | 13 |
| Participants | Placebo | AC-201 |
|---|---|---|
| Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL | 33 | 43 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/60 (0%) | 0/60 (0%) | 29/60 (48.3%) |
| AC-201 | 0/67 (0%) | 0/67 (0%) | 43/67 (64.2%) |
| Event | Placebo | AC-201 |
|---|---|---|
| Gastrointestinal disordersGastrointestinal disorders | 7/60 | 25/67 |
| InvestigationsInvestigations | 6/60 | 6/67 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 6/60 | 6/67 |
| Infections and infestationsInfections and infestations | 5/60 | 6/67 |
| Nervous system disordersNervous system disorders | 1/60 | 4/67 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 2/60 | 0/67 |
| Skin And subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 2/60 | 1/67 |
| Hepatobiliary disordersHepatobiliary disorders | 1/60 | 2/67 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 1/60 | 0/67 |
| Cardiac disordersCardiac disorders | 1/60 | 0/67 |
| Age, Continuous(years) | Placebo | AC-201 | Total |
|---|---|---|---|
| Mean | 47.5 ± 13.1 | 47.3 ± 11.7 | 47.4 ± 12.3 |
| Sex: Female, Male(Participants) | Placebo | AC-201 | Total |
|---|---|---|---|
| Female | 1 | 5 | 6 |
| Male | 59 | 62 | 121 |
| Race (NIH/OMB)(Participants) | Placebo | AC-201 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 60 | 67 | 127 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | AC-201 | Total |
|---|---|---|---|
| Taiwan | 60 | 67 | 127 |
The record gives a start of Dec 2014, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2020, 4 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diacerein
TWi Biotechnology, Inc.