NCT07842497

Brief Summary

It is a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanized monoclonal antibody injection in subjects with acute gout flare

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
27mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2027

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 14, 2026

Last Update Submit

September 21, 2026

Conditions

Acute Gouty Arthritis

Keywords

acute gouty arthritis

Outcome Measures

Primary Outcomes (1)

  • The change in the gout pain intensity in the target joint measured by VAS

    The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

    72 hours post-dose

Secondary Outcomes (14)

  • Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)

    up to 24 weeks

  • The change in the gout pain intensity in the target joint measured by VAS.

    up to 24 weeks

  • The number of patients with at least 1 new gout flare

    up to 24 weeks

  • Time to at Least a 50%，70% Reduction in Baseline Pain Intensity

    up to 120 hours

  • Percent Patients Who Took Rescue Medication

    up to 24 weeks

  • +9 more secondary outcomes

Study Arms (2)

Compound Betamenth Group

ACTIVE COMPARATOR

Intramuscular injection 2ml/bottle

Drug: Compound Betamenth Group

IBI3011 GROUP

EXPERIMENTAL

Subcutaneous injection 300mg/bottle

Drug: IBI3011 GROUP

Interventions

Compound Betamenth GroupDRUG

Intramuscular injection 2ml/bottle

Compound Betamenth Group
IBI3011 GROUPDRUG

Subcutaneous injection 300mg/bottle

IBI3011 GROUP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and sign the informed consent form;
  • Aged 18 to 75 years, male or female, male or female;
  • Body Mass Index (BMI) between 18.0 kg/m² and 40.0 kg/m²;
  • Meets the 2015 American College of Rheumatology (ACR) Gout Classification Criteria;
  • Has a history of at least 2 gouty arthritis flares within 1 year prior to study drug administration;
  • With an acute gouty arthritis flare occurring within 4 days before study drug administration;
  • Has contraindications to, intolerance of, or inadequate response to colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDs);
  • At screening, has a Visual Analogue Score (VAS) pain score of ≥50 mm (on a 0-100 mm scale) in the target joint affected by the acute gout flare
  • Agrees to comply with the protocol-specified urate-lowering therapy (ULT) during the study period;
  • Has no childbearing plans and can use adequate contraceptive measures during the trial period and for 6 months after the last dose of study drug
  • Subjects meeting any of the following criteria are not eligible to attend this clinical study:
  • Have a history of specific allergies (such as asthma, urticaria, eczema, etc.) or hypersensitivity reactions to previous use of biological agents, or atopic diathesis (e.g., allergies to two or more types of drugs, foods, and pollen);
  • Difficulties in venous blood collection or history of dizziness when encountering blood or needles;
  • Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
  • Have live or attenuated vaccination in the 3 months prior to randomization or plan to receive that during the this trial;
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Fudan University

Jing’an, Shanghai Municipality, 200040, China

Location

Central Study Contacts

Kai Shao

CONTACT

86 0512-69566088kai.shao@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 25, 2026

Study Start (Estimated)

October 28, 2026

Primary Completion (Estimated)

May 11, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

CN(1)