Phase 3 Study of Dotinurad vs Allopurinol in Participants With Gout

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Crystalys Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

2 Dec 2025 → ongoing

Decision date (initial)

2025-10-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Crystalys Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.

Secondary objectives 2

1. 1. To evaluate the efficacy of dotinurad in reducing gout flares and other clinically relevant efficacy measures compared with allopurinol.
2. 2. To assess the safety and tolerability of dotinurad compared with allopurinol.

Conditions and MedDRA coding

Hyperuricemia associated with gout.

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Provide written informed consent and any authorizations required by local law.
2. 2. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
3. 3. Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
4. 4. Had at least 2 gout flares in the 12 months prior to Screening
5. 5. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening.
6. 6. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
7. 7. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
8. 8. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.

Exclusion criteria 7

1. 1. History of or presence of kidney stones within 1 year prior to Screening.
2. 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
3. 3. Hypersensitivity or intolerance to dotinurad or to colchicine AND NSAIDs.
4. 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse
5. 5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
6. 6. Participants with unstable long-term conditions, such as diabetes, high cholesterol, hypertension, asthma, etc.
7. 7. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.

Secondary endpoints 3

1. 1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive.
2. 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64.
3. 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Crystalys Therapeutics Inc.

Sponsor organisation

Crystalys Therapeutics Inc.

Address

12544 High Bluff Drive Suite 310

City

San Diego

Postcode

92130-3049

Country

United States

Scientific contact point

Organisation

Crystalys Therapeutics Inc.

Contact name

Chief Medical Officer

Public contact point

Organisation

Crystalys Therapeutics Inc.

Contact name

Chief Medical Officer

Third parties 9

Locations

2 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 61 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications