A study to assess the efficacy and safety of tigulixostat at different doses as compared to a control drug (allopurinol) in gout patients with hyperuricemia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

LG Chem Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

9 Apr 2024 → 6 May 2025

Decision date (initial)

2023-12-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

LG Chem, Ltd.

External identifiers

EU CT number

2022-501421-20-00

WHO UTN

U1111-1282-3040

ClinicalTrials.gov

NCT05586971

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacokinetic, Therapy

To compare the efficacy of tigulixostat to appropriately titrated allopurinol (up to 800 mg/day) in achieving sUA levels of <6 mg/dL at Months 4, 5, and 6.

Secondary objectives 4

1. To compare the efficacy of tigulixostat to appropriately titrated allopurinol (up to 800 mg/day) in achieving sUA levels of <5 mg/dL at Months 4, 5, and 6.
2. To assess the incidence of flare events from Month 6 to Month 12 of tigulixostat and appropriately titrated allopurinol treatment in gout patients with hyperuricemia.
3. To compare the efficacy of tigulixostat to appropriately titrated allopurinol (up to 800 mg/day) in tophi regression and resolution.
4. To evaluate the safety of tigulixostat in gout patients with hyperuricemia.

Conditions and MedDRA coding

Gout with hyperuricemia

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subject or the subject’s legally acceptable representative is willing and able to provide written ICF prior to the initiation of any study procedures.
2. Male or female subjects between the ages of 18 and 85 years, inclusive.
3. Subjects with hyperuricemia and a history or presence of gout per ACR/EULAR 2015 criteria (Neogi et al 2015).
4. Subjects who are currently on ULT with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have a sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
5. Subjects with a BMI ≤50 kg/m2 at screening (Visit 1).
6. Subjects with eGFR ≥30 mL/min/1.73m2 at screening (Visit 1).

Exclusion criteria 6

1. Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder or their treatment, organ transplant, therapeutic regimens that produce hyperuricemia, renal failure, renal tubular disorders, lead poisoning, hyperproliferative skin disorders, enzymatic defects (eg, deficient hypoxanthine-guanine phosphoribosyl transferase, glycogen storage diseases)).
2. Subjects experiencing an active acute gout attack within 2 weeks prior to screening (Visit 1).
3. Subjects who are Asian descent (eg, Han Chinese, Korean, Thai) and Black/African descent (eg. African American) with a positive test for HLA B*58:01.
4. Subjects who have received uricase (e.g., pegloticase).
5. Subjects who have not been receiving stable doses of drugs known to affect sUA levels (losartan, fibrates, thiazide diuretics, loop diuretics, ASA) for the last 3 weeks prior to screening (Visit 1). Acetylsalicylic acid use more than 325 mg/day is not allowed.
6. Subjects with a history of xanthinuria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.

Secondary endpoints 8

1. Proportion of subjects with sUA levels <5.0 mg/dL sustained at Months 4, 5, and 6.
2. Proportion of subjects with at least one gout flare from Month 6 to Month 12.
3. Proportion of subjects with complete resolution (100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression) of ≥1 target tophus by Month 12.
4. Adverse Events (AEs).
5. Serious adverse events (SAEs).
6. Treatment-Emergent Adverse events (TEAEs).
7. Adverse Events of Special Interest (AESI) including MACE, hepatic injury, renal events, and serious skin and hypersensitivity reactions.
8. Physical examinations, vital signs, clinical safety laboratory parameters, or ECGs.

Investigational products

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

Test 2

Comparator 3

Placebo 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

LG Chem Ltd.

Sponsor organisation

LG Chem Ltd.

Address

128 Yeoui-Daero, Yeongdeungpo-Gu Yeongdeungpo-Gu

City

Seoul

Postcode

07336

Country

Korea, Republic of

Scientific contact point

Organisation

LG Chem Ltd.

Contact name

LG Chem Clinical Research

Public contact point

Organisation

LG Chem Ltd.

Contact name

LG Chem Clinical Research

Third parties 9

Locations

9 EU/EEA countries · 70 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Urgent safety measures 1 · Art. 54 CTR

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 203 files

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

Application history

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