Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares

NCT07346079 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P001469
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare. The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period. The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.

Conditions

Gout; Gout Arthritis; Gout Flare

Outcome Measures

Primary Outcomes (1)

• Change in gout pain intensity from baseline in target join to 72 hours post-injection

  Change in gout pain intensity from baseline in the target joint following PCG administration measured by Visual Analog Scale (VAS) at 72 hours post-injection (Day 3; Visit 2). Patients will score their pain intensity in the joint most affected at baseline (i.e., the index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100).

  From baseline to Day 3/Visit 2

Secondary Outcomes (12)

• Change in gout pain from baseline in target joint at Day 1

  From baseline to Day 1

• Change in gout pain intensity from baseline in target joint to Day 2

  From baseline to Day 2

• Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.

  From baseline to Day 7

• Time to onset of effect (≥20% change from baseline pain intensity on VAS).

  From baseline to end of study (Day 7)

• Time to response (≥50% change from baseline pain intensity on VAS).

  From baseline to end of study (Day 7)

Other Outcomes (2)

• Levels of inflammatory markers (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])

  From baseline to Day 3/Visit 2

• Change from baseline in health-related quality-of-life Gout Attack Intensity Score (GAIS) at Day 0 (Visit 1) and at Day 3 (72-hours post-injection; Visit 2) (19).

  From baseline to Day 3/Visit 2

Study Arms (2)

Purified Cortophin Gel 40 U

EXPERIMENTAL

Patients in this arm will receive the 40 U dose at Day 0

Drug: Purified Cortophin Gel, 40 U

Purified Cortophin Gel 80 U

EXPERIMENTAL

Patients in this arm will receive the 80 U dose at Day 0

Drug: Purified Cortophin Gel 80 U

Interventions

Purified Cortophin Gel, 40 U DRUG

This will be the 40 U dose of the purified Cortophin Gel

Purified Cortophin Gel 40 U

Purified Cortophin Gel 80 U DRUG

This will be the 80 U dose of the purified Cortophin Gel

Purified Cortophin Gel 80 U

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in this study
• Male and female patients, aged 18-85 years
• Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
• Onset of current acute gout flare within 5 days prior to study entry
• Body mass index of less than or equal to 45 kg/m2
• Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
• History of ≥ 1 gout flares within the 12 months prior to study entry
• The patient meets at least one of the following criteria for both NSAIDs and colchicine treatment options:
• Minimum of one episode of being intolerant, or unresponsive to the treatment, see Appendices 2-4.
• The investigator deems the patient is either contraindicated or inappropriate for the treatment. Inappropriateness could be due to anticipated changes in patient status (i.e., such as worsening of comorbidities or use of concomitant medication), see Appendices 2-4.
• Patients must be willing and capable of using an electronic device (e.g., cellphone) and must have access to a cellphone to be able to complete surveys.

You may not qualify if:

• Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2 weeks prior to randomization or have an unhealed operation wound(s)), history of or the presence of a peptic ulcer, uncontrolled congestive heart failure, uncontrolled hypertension, uncontrolled diabetes type 1 or 2, or sensitivity to proteins derived from porcine sources.
• Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
• Rheumatoid arthritis, evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Polyarticular gouty arthritis involving more than 4 joints.
• Participation in another concurrent investigational study within 30 days of randomization or has taken an investigational drug within five times the half-life of that investigational drug has passed.
• Presence of severe renal function impairment: estimated creatinine clearance \<30 mL/min/1.73m2 (CKD stages 4 and 5).
• Uncontrolled clinically significant hematologic, CNS, hepatic, pulmonary, gastrointestinal, metabolic, or endocrine disease as deemed by the investigator.
• Presence of any medical or psychological condition or laboratory result that might create risk to the patients (or interfere with the patient's ability to comply with the protocol requirements, or to complete the study) in the opinion of the investigator.
• Prior or current treatment with any ACTH product.
• Pregnant or nursing (lactating) women. Women of childbearing age are required to be using an acceptable method of contraception.
• Patients taking urate-lowering therapy had to be on a stable dose and regimen for ≥2 weeks before entering the study and remain on a stable dosage and regimen for at least 1 week after Purified Cortrophin® Gel.
• Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor \[TNF\] inhibitors) within specified periods (see Appendix 5) prior to randomization.
• Vaccination within 30 days prior to study enrollment and during the study period.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ANI Pharmaceuticals: collaborator

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Gouty; Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hyon K Choi, MD, DrPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana D Fernandes, MA

CONTACT

617-643-2140; adfernandes@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Investigator

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 16, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)