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

A Randomized, Multicenter, Double-blind, Efficacy and Safety Study of 2 Dose Levels of Purified Cortrophin® Gel in Patients With Acute Gouty Arthritis Flares

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.

Study Overview

• Status: Recruiting
• Conditions: Gout; Gout Flare; Gout Arthritis
• Intervention / Treatment: Drug: Purified Cortophin Gel, 40 U; Drug: Purified Cortophin Gel 80 U

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ana D Fernandes, MA; Phone Number: 617-643-2140; Email: adfernandes@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Mass General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Previous inclusion in this study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Purified Cortophin Gel 40 U; Patients in this arm will receive the 40 U dose at Day 0	Drug: Purified Cortophin Gel, 40 U; This will be the 40 U dose of the purified Cortophin Gel
Experimental: Purified Cortophin Gel 80 U; Patients in this arm will receive the 80 U dose at Day 0	Drug: Purified Cortophin Gel 80 U; This will be the 80 U dose of the purified Cortophin Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gout pain from baseline in target joint at Day 1	Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration measured by Visual Analog Scale (VAS) at Day 1 (24 hours post-injection). Minimum value: 0 Maximum value: 10 Higher score indicates worse outcome.	From baseline to Day 1
Change in gout pain intensity from baseline in target joint to Day 2	Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration as measured by Visual Analog Scale (VAS) at Day 2 (48 hours post-injection). Minimum value: 0 Maximum value: 10 Higher score indicates worse outcome.	From baseline to Day 2
Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.	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).	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).	Time to response (≥50% change from baseline pain intensity on VAS).	From baseline to end of study (Day 7)
Patient Global Self-Assessment to treatment: (24 hours, 48 hours, 72 hours, and Day 7 post-injection).	Patient Global Self-Assessment to treatment: (24 hours, 48 hours, 72 hours, and Day 7 post-injection). 4 - Excellent 3 - Good 2 - Acceptable 1 - Slight 0 - Poor Lower scores indicate worse outcomes.	From baseline to end of study (Day 7)
Physician assessment of inflammatory signs: (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])	Physician assessment of inflammatory signs: (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2]); Physician assessment of joint tenderness0 - No pain- Mild/patient there is pain when touched- Moderate/patient states there is pain and winces- Severe/patient states there is pain, winces and withdraws.; Physician assessment of joint swelling0 - No swelling- Mild swelling/palpable- Moderate swelling/visible- Severe swelling/bulging beyond the joint margins; Physician assessment of erythema Absent or Present o Physician assessment of target joint range of motion 0 - Normal; - Mildly restricted; - Moderately restricted; - Severely restricted; - Immobilized The above answers will be totaled - minimum value: 0, max: 12. Higher values indicate worse outcomes.	From baseline to end of study (Day 7)
Physician assessment of local tolerability at injection site (at 72 hours post-injection).	Physician assessment of local tolerability at injection site (at 72 hours post-injection) Notes presence of redness, swelling, pain, bruising, itching (no numerical values).	Day 3 (Visit 2)
Use of rescue medication (up to 72-hours post-injection).	Use of rescue medication (up to 72-hours post-injection).	From baseline to Day 3/Visit 2
Safety assessment - AEs, SAEs	Notes presence, description, duration of an AE, and whether the AE is serious.	From baseline to end of study (Day 7)
Safety Assessment - Vital Signs	Height and Weight will be collected, and used to calculate the participant's BMI	Day 1 Visit and Day 3 Visit
Safety Assessment - Laboratory Measurements	Biochemistry: Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Total bilirubin (if >upper limit of normal also conjugated and non-conjugated bilirubin) Alkaline phosphatase (ALP） Prothrombin Time/International Normalized Ratio (PT/INR)‡¥§ Albumin Cholesterol (total, LDL, and HDL) Triglycerides Creatinine◊§ Sodium (Na) Potassium (K) Ferritin Erythrocyte sedimentation rate Uric acid Glucose*¥ HbA1c Troponin T C-reactive protein (CRP) Serum amyloid A (SAA) Calcium Magnesium Hematology: Hemoglobin Hematocrit White blood cells Differential blood count Thrombocytes Urine analysis: Albumin U-erythrocytes Abnormal test findings, if changed significantly from baseline will be noted. Minimum and maximum values, as well as indications of higher or lower values vary depending on the test.	Day 1 and Day 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of inflammatory markers (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])	Levels of inflammatory markers (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2]); C-reactive protein; Serum amyloid A	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).	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).; How much pain is your gout causing you today? (color in one box completely)1 No pain2 Mild pain3 Moderate pain4 A lot of pain5 Extreme pain; How tender to the touch are the gout-affected parts of your body today? (colour in one box completely)1 Not tender2 Slightly tender3 Fairly tender4 Very tender5 Extremely tender; How swollen are the gout-affected parts of your body today? (colour in one box completely)1 Not swollen2 Somewhat swollen3 Fairly swollen4 Very swollen5 Extremely swollen The answers across all three questions will be totaled, with higher scores indicating worse outcomes. Minimum value: 3, maximum value: 15	From baseline to Day 3/Visit 2

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: ANI Pharmaceuticals
• Investigators: Principal Investigator: Hyon K Choi, MD, DrPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Gout; Arthritis, Gouty
• Other Study ID Numbers: 2025P001469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be shared with the sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes