Using IC14 to treat acute decompensated heart failure

Phase 1b Pilot Study to Evaluate Atibuclimab (IC14) for Treatment of Acute Decompensated Heart Failure

This study is testing a new drug called IC14 to see if it can safely help adults in the hospital with acute heart failure feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Implicit Bioscience (Industry-sponsored)
• Drugs / interventions: prednisone, atibuclimab
• Locations: 2 sites (Charlottesville, Virginia and 1 other locations)
• Trial ID: NCT06556810 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and exploratory efficacy of the drug atibuclimab (IC14) administered via intravenous infusion in adults hospitalized with acute decompensated heart failure (ADHF). Participants will receive a single dose of IC14 and will be monitored for safety and clinical outcomes through various assessments, including biomarkers and heart performance measures. The study will track treatment-emergent adverse events, laboratory safety studies, and the drug's pharmacokinetics. Follow-up visits will occur in the hospital or clinic, with additional phone check-ins three months post-infusion.

Who should consider this trial

Good fit: Ideal candidates for this study are adults hospitalized with acute decompensated heart failure and documented impaired left ventricular systolic function.

Not a fit: Patients with heart failure not meeting the specific inclusion criteria, such as those without elevated cardiac filling pressure or pulmonary congestion, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute decompensated heart failure.

How similar studies have performed: While this approach is exploratory, previous studies have shown promise in treating heart failure with novel therapies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

Patients may be included in the study only if they meet all of the following criteria:

1. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:

   1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
   2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):

      * Pulmonary congestion/edema a physical exam OR chest x-ray;
      * plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or
      * invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg.
2. The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months).
3. The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours.
4. The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
5. The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms).
6. The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
7. Males and females of childbearing potential must use effective contraception.

Exclusion Criteria:

1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration.
3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
4. Previous or planned implantation of left ventricular assist devices or heart transplant.
5. Current or planned use of intravenous inotropes.
6. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs or colchicine).
7. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
8. Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
9. Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer.
10. Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
11. Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.
12. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients).
13. Pregnancy.
14. Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.

Where this trial is running

Charlottesville, Virginia and 1 other locations

• University of Virginia — Charlottesville, Virginia, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Antonio Abbate, MD — University of Virginia
• Study coordinator: Antonio Abbate, MD

Conditions Acute Decompensated Heart Failure; Congestive Heart Failure; Left Heart Failure; Heart Failure