Phase 1b Pilot Study to Evaluate Atibuclimab (IC14) for Treatment of Acute Decompensated Heart Failure
New Drug Trial for Acute Decompensated Heart Failure
Plain English Summary
IC14 for Treatment of Acute Decompensated Heart Failure is a Phase 2 clinical trial sponsored by Implicit Bioscience studying Acute Decompensated Heart Failure. This trial tests a new drug called Atibuclimab (IC14) for adults hospitalized with severe heart failure. It is for patients experiencing sudden worsening of heart failure symptoms, including difficulty breathing. Participants will receive one dose of the drug intravenously and have several follow-up visits and a phone call. There are no alternative treatments offered within this specific trial; standard medical care will continue. The trial aims to enroll 10 participants.
Official Summary
The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. The main questions it aims to answer are: Is the drug IC14 safe in patients with ADHF? What are the IC14 drug levels in the bloodstream after treatment with IC14? What is the impact of IC14 treatment on markers of disease in the bloodstream? What is the impact of IC14 treatment on measures of heart failure? There is no placebo arm in this study. Participants will: Take drug IC14 once via an intravenous infusion After the infusion, be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients must be at least 21 years old and hospitalized for a primary diagnosis of worsening heart failure. They must have evidence of fluid in the lungs or elevated heart failure markers, and a history of reduced heart pumping function. Patients experiencing significant shortness of breath and who have recently received or are scheduled for IV diuretics may be eligible. Individuals with certain other serious health conditions, recent heart surgeries, or those taking specific medications may not be able to participate. This trial is studying Acute Decompensated Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes will show if Atibuclimab (IC14) is safe for patients with severe heart failure and how the drug behaves in the body, which is crucial for understanding its potential benefits. The specific primary outcome measures are: Safety of IC14 treatment (0-28 days); Anti-Drug Antibodies following IC14 treatment (0-28 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it explores a new treatment option for acute decompensated heart failure, a condition with significant unmet medical needs and high hospitalization rates. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Acute Decompensated Heart Failure, where improved treatment options are needed.
Investor Insight
This Phase 2 study by Implicit Bioscience signals a focused effort to address a large market of heart failure patients, with early safety and efficacy data being key to future investment and developme Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if Atibuclimab (IC14) is appropriate for your specific condition and if you meet all the study requirements. Participation involves receiving the drug through an IV and attending multiple follow-up appointments for tests and check-ups. You will also have a phone call about three months after receiving the drug to discuss your health status. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- DRUG: Atibuclimab (IC14) — Atibuclimab (IC14) is a monoclonal antibody against human cluster of differentiation (CD)14, a key signaling molecule of the innate immune system
Primary Outcomes
- Safety of IC14 treatment (0-28 days)
- Anti-Drug Antibodies following IC14 treatment (0-28 days)
Secondary Outcomes
- C-reactive protein, biomarker of inflammation (baseline, 24 hours, 72 hours or discharge, Day 10, Day 29)
- B-type natriuretic peptide, biomarker of heart failure (baseline, 24 hours, 72 hours or discharge, Day 10, Day 29)
- Estimated glomerular filtration rate, biomarker of heart failure (baseline, 72 hours or discharge, Day 10, Day 29)
- Urine sodium (baseline, 24 hours, 72 hours or discharge)
- Dyspnea Visual Analogue Scale (baseline, 24 hours, 72 hours, Day 10, Day 29, and 3 months (virtual).)
Trial Locations
- University of Virginia, Charlottesville, Virginia, United States
- Virginia Commonwealth University, Richmond, Virginia, United States
Frequently Asked Questions
What is clinical trial NCT06556810?
NCT06556810 is a Phase 2 INTERVENTIONAL study titled "IC14 for Treatment of Acute Decompensated Heart Failure." It is currently active, not recruiting and is sponsored by Implicit Bioscience. The trial targets enrollment of 10 participants.
What conditions does NCT06556810 study?
This trial investigates treatments for Acute Decompensated Heart Failure. The primary condition under study is Acute Decompensated Heart Failure.
What treatments are being tested in NCT06556810?
The interventions being studied include: Atibuclimab (IC14) (DRUG). Atibuclimab (IC14) is a monoclonal antibody against human cluster of differentiation (CD)14, a key signaling molecule of the innate immune system
What does Phase 2 mean for NCT06556810?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06556810?
This trial is currently "Active, Not Recruiting." It started on 2024-10-17. The estimated completion date is 2026-08-28.
Who is sponsoring NCT06556810?
NCT06556810 is sponsored by Implicit Bioscience. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06556810?
The trial aims to enroll 10 participants. The trial status is active, not recruiting.
How is NCT06556810 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06556810?
The primary outcome measures are: Safety of IC14 treatment (0-28 days); Anti-Drug Antibodies following IC14 treatment (0-28 days). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06556810 being conducted?
This trial is being conducted at 2 sites, including Charlottesville, Virginia; Richmond, Virginia (United States).
Where can I find official information about NCT06556810?
The official record for NCT06556810 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06556810. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06556810 testing in simple terms?
This trial tests a new drug called Atibuclimab (IC14) for adults hospitalized with severe heart failure. It is for patients experiencing sudden worsening of heart failure symptoms, including difficulty breathing.
Why is this trial significant?
This trial is important because it explores a new treatment option for acute decompensated heart failure, a condition with significant unmet medical needs and high hospitalization rates.
What are the potential risks of participating in NCT06556810?
The main risks involve potential side effects from the drug Atibuclimab (IC14), which will be closely monitored. As with any new treatment, there's a possibility of unexpected reactions or complications related to the drug or the study procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06556810?
Ask your doctor if Atibuclimab (IC14) is appropriate for your specific condition and if you meet all the study requirements. Participation involves receiving the drug through an IV and attending multiple follow-up appointments for tests and check-ups. You will also have a phone call about three months after receiving the drug to discuss your health status. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06556810 signal from an investment perspective?
This Phase 2 study by Implicit Bioscience signals a focused effort to address a large market of heart failure patients, with early safety and efficacy data being key to future investment and developme This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive one dose of the drug intravenously and have several follow-up visits and a phone call. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Acute Decompensated Heart Failure Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.