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Acute GoutPhase 1/2NCT05328531

Clinical Study of Genakumab for Injection in Patients With Acute Gout

A Phase 1/2 study testing Genakumab for Injection in people with Acute Gout, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Gout
What is being tested?
Genakumab for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
1 siteChina
Study dates
22 May 2021to 9 Jun 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years ≤ age ≤65 years
  • Meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of acute arthritis of primary gout
  • Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
  • Body mass index of less than or equal to 45 kg/m2
  • Onset of current acute gout flare within 5 days prior to study entry
  • Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
  • History of gout flare prior to study entry

Who cannot join

  • evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
  • Presence of severe renal function impairment
  • Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry
  • Live vaccinations within 3 months prior to randomization
  • Requirement for administration of antibiotics against latent tuberculosis (TB)
  • Any active or recurrent bacterial, fungal, or viral infection
  • QTc>450ms for male, QTc>470ms for female

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 310000

Other trials in China

About this study

Official title: The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Read the detailed description

Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.

Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.

Conditions
Acute Gout
Being tested
Genakumab for Injection, Placebo for Genakumab for Injection
Keywords
acute gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genakumab for InjectionDrug

    150 mg/1ml/bottle

  • Placebo for Genakumab for InjectionDrug

    The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Study groups in NCT05328531
Study groupRoleWhat they receive
Genakumab for injection 50mg (Ib)Experimentalsubcutaneous injection, single dose
Receives: Drug: Genakumab for Injection
Genakumab for injection 100mg (Ib)Experimentalsubcutaneous injection, single dose
Receives: Drug: Genakumab for Injection
Genakumab for injection 195mg (Ib)Experimentalsubcutaneous injection, single dose
Receives: Drug: Genakumab for Injection
Genakumab for injection 100mg (II)ExperimentalGenakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Receives: Drug: Genakumab for Injection
Genakumab for injection 195mg (II)ExperimentalGenakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Receives: Drug: Genakumab for Injection
Compound Betamethasone Injection 1ml (II)Active comparatorCompound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
Receives: Drug: Placebo for Genakumab for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax)

    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

    Measured: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112

  2. pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)

    0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain

    Measured: 72 hours post-dose

Secondary outcomes (2)

  1. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards

    Measured: up to 16 weeks

  2. High Sensitivity C-reactive Protein (hsCRP)

    High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (except Visit 2 and Visit 4 ) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.

    Measured: at 72 hours and 7 days, 4, 8 and 12 weeks post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start22 May 2021
  3. Primary completion9 Jun 2022
  4. Study completion9 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A : 50mg by single subcutaneous injection; Group B : 100mg by single subcutaneous injection Group C : 195mg by single subcutaneous injection;Group D : 100mg by single subcutaneous injection Group E : 195mg by single subcutaneous injection; Group F: 1ML Compound Betamethasone Injection by single intramuscular injection
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328531
Sponsor's protocol ID
Gensci048GA-Ib/II
Status last verified
Feb 2025
First submitted
29 Mar 2022
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xue Y, Zhang N, Hu J, Gou W, Chen L, Tang L, Li Y, Ma L, Zhang Z, Li M, Dong L, Duan X, Qin L, Yuan G, Miao L, Wu J, Qian L, Hu W, Tan W, Li J, Da Z, Xu Q, Chen C, Luo T, Zhang J, Zou H. Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Firsekibart in Gout: A Phase Ib/II Clinical Trial. Int J Rheum Dis. 2026 Jul;29(7):e70785. doi: 10.1111/1756-185x.70785.

    PubMed 42498684

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Genakumab for Injection in people with Acute Gout, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05328531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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