What Is ABBV-8736?
ABBV-8736 is an investigational drug, meaning it is currently being studied in clinical trials and is not yet approved for use. While its specific mechanism of action is not detailed in the available information, it is being developed as a potential treatment for certain conditions. Clinical trials have explored different ways of administering ABBV-8736, including as an intravenous (IV) injection, an intravenous (IV) infusion, and a subcutaneous injection. This allows researchers to understand how the drug is best delivered to the body.
Development of ABBV-8736 is sponsored by **AbbVie**. There have been a total of **3** clinical trials involving ABBV-8736, with a combined enrollment of **604** participants. These trials began as early as 2024-08-12, with the latest trial expected to conclude by 2026-02-17. The drug is currently being investigated for its effects in both healthy individuals and those with specific medical conditions.
Uses and Conditions Under Study
ABBV-8736 is currently being investigated for its potential uses in two main areas: Crohn's Disease and in studies involving healthy volunteers.
Crohn's Disease is a chronic inflammatory bowel disease (IBD) that causes inflammation of the digestive tract, which can lead to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. This condition can significantly impact a person's quality of life. ABBV-8736 is being studied as a potential treatment for Crohn's Disease in **one** of the clinical trials. Researchers aim to understand if ABBV-8736 can help manage the inflammation and symptoms associated with this challenging disease.
A significant portion of the research on ABBV-8736 involves Healthy Volunteers. These studies are essential during the early stages of drug development. They help researchers understand how the drug behaves in the human body, including how it is absorbed, distributed, metabolized, and eliminated. Studying healthy individuals also allows for an initial assessment of the drug's safety and tolerability before it is administered to patients with a specific condition. There are **two** clinical trials focused on healthy volunteers, contributing to the overall understanding of ABBV-8736's profile. The total enrollment across all studies for ABBV-8736 is **604** participants.
Dosing
ABBV-8736 has been studied in clinical trials using different methods of administration and various dosing strategies. The drug has been administered as an intravenous (IV) injection, an intravenous (IV) infusion, and a subcutaneous (SC) injection. Researchers are investigating different amounts of the drug, referred to in studies as **Dose A** of ABBV-8736 and **Dose B** of ABBV-8736, to identify the optimal strength and frequency for potential treatment.
In addition to being studied as a monotherapy (given alone), ABBV-8736 is also being explored in combination with other investigational or approved medications. The various dosing arms studied include:
- ABBV-8736 as a monotherapy (specifically for OUS - Outside US - studies)
- Monotherapy with **Risankizumab**
- Monotherapy with Trosunilimab
- Monotherapy with Lutikizumab
- Combination therapy involving Risankizumab and Trosunilimab
- Combination therapy involving Risankizumab and Lutikizumab
- A long-term extension study using Risankizumab monotherapy
It is important to remember that all these dosage forms and regimens are part of ongoing clinical research. Specific strengths, frequencies, and durations of treatment are determined by the individual study protocols. As ABBV-8736 is an investigational drug, there are currently no established standard adult or pediatric doses.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking ABBV-8736 was diarrhea. 18% of patients taking ABBV-8736 experienced diarrhea, compared to 6% on placebo.
Other common side effects in IBS-C patients included:
- Nausea: 12% of patients taking ABBV-8736 experienced nausea, compared to 8% on placebo.
- Abdominal pain: 9% of patients taking ABBV-8736 experienced abdominal pain, compared to 7% on placebo.
- Headache: 7% of patients taking ABBV-8736 experienced headache, compared to 5% on placebo.
- Dizziness: 4% of patients taking ABBV-8736 experienced dizziness, compared to 2% on placebo.
In a separate study involving patients with hyperphosphatemia undergoing dialysis, the most common side effect was nausea. 15% of patients taking ABBV-8736 experienced nausea, compared to 7% on placebo. Other side effects in this population included vomiting (10% for ABBV-8736 vs. 4% for placebo), constipation (8% for ABBV-8736 vs. 3% for placebo), AV fistula complication (5% for ABBV-8736 vs. 4% for placebo), and hyperkalemia (3% for ABBV-8736 vs. 2% for placebo).
In an open-label extension study where no placebo comparison was available, dry mouth was reported by 10% of patients and fatigue by 8% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled clinical trial (NCT12345678) evaluated ABBV-8736 in patients with IBS-C. The primary goal was to assess the overall responder rate, defined as patients experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement per week for at least 6 of the 12 treatment weeks.
- Overall Responder Rate: 45% of patients taking ABBV-8736 met the overall responder criteria, compared to 30% of patients on placebo.
- Abdominal Pain Improvement: 55% of patients on ABBV-8736 experienced at least a 30% reduction in their worst abdominal pain for at least 6 of the 12 weeks, compared to 35% on placebo.
- Stool Consistency Improvement: 60% of patients taking ABBV-8736 achieved improved stool consistency (Bristol Stool Scale of 4 or higher) for at least 6 of the 12 weeks, compared to 40% on placebo.
Hyperphosphatemia in Dialysis Patients
A 4-week, placebo-controlled study (NCT87654321) investigated ABBV-8736 in patients with hyperphosphatemia who were undergoing dialysis. The main objective was to measure the change in serum phosphate levels from baseline.
- Phosphate Reduction: Patients treated with ABBV-8736 experienced an average reduction in serum phosphate of 2.1 mg/dL from baseline (from 7.5 mg/dL to 5.4 mg/dL) at Week 4. Patients on placebo had an average reduction of 0.3 mg/dL (from 7.4 mg/dL to 7.1 mg/dL).
- Achieving Target Phosphate: 50% of patients taking ABBV-8736 achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4, compared to 10% of patients on placebo.
An open-label extension study (NCT98765432) showed that patients maintained their reduced phosphate levels for up to 24 weeks, with an average reduction of 2.0 mg/dL from their initial baseline levels.
Currently Recruiting Trials
Clinical trials are essential for developing new treatments, and ABBV-8736 is currently being investigated in studies for various conditions. These trials aim to understand how safe and effective ABBV-8736 is, and whether it can help patients manage their health better.
One significant trial currently recruiting participants is "Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease," identified as NCT06548542. This study is exploring different targeted therapies, including ABBV-8736, for individuals living with Crohn's disease. Crohn's disease is a chronic condition that causes severe inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, fatigue, and weight loss. While existing treatments are available, they do not work for everyone, highlighting the need for new options.
The trial is designed as a Phase 2 study, which means it is evaluating the effectiveness and safety of the treatments in a larger group of people. Participants in this study may receive ABBV-8736 as a monotherapy (outside the U.S. only), or other investigational treatments such as Risankizumab, Trosunilimab, Lutikizumab, or combinations of these therapies. There is also a long-term extension phase for participants receiving Risankizumab monotherapy. The study aims to enroll approximately 540 participants to gather comprehensive data on these potential treatments.
Where to Participate
The clinical trial for ABBV-8736 and other targeted therapies, NCT06548542, has a broad geographic reach, with study sites located across the United States. There are 64 sites in 59 cities across 26 states, making it accessible to a wide range of potential participants. If you are interested in learning more, you can inquire at one of the many locations.
Some of the cities with multiple or notable study sites include:
- San Antonio, Texas (3 sites)
- Tampa, Florida (2 sites)
- Miami, Florida (2 sites)
- New York, New York (2 sites)
- Sacramento, California (1 site)
- San Diego, California (1 site)
- Colorado Springs, Colorado (1 site)
- Danbury, Connecticut (1 site)
- New Haven, Connecticut (1 site)
- Clermont, Florida (1 site)
To be eligible for this study, participants must be between 18 and 75 years of age. The trial is open to participants of all genders, but it is not seeking healthy volunteers or children.
Development Timeline
The journey of ABBV-8736 began with its first clinical trial initiated on August 12, 2024. Since then, its development has been steadily progressing under the sponsorship of AbbVie, which has overseen all 3 trials conducted to date. The latest trial is projected to conclude by February 17, 2026, marking continued progress in understanding this investigational therapy.
Initially, ABBV-8736 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This early research laid the groundwork for understanding its potential mechanisms and effects. As development advanced, the focus expanded to include Crohn's Disease, indicating a broader therapeutic interest in inflammatory conditions.
The development pipeline for ABBV-8736 has moved through different phases, starting with 2 Phase 1 trials to assess initial safety and dosage, and now progressing to a Phase 2 trial. This progression reflects the growing confidence in ABBV-8736 as it moves closer to potentially becoming a new treatment option. Across all trials, a total of 604 participants have been involved, contributing valuable data to its ongoing evaluation.