What Is ABBV-438?
ABBV-438 is an investigational drug currently being studied in clinical trials. It is not yet approved by regulatory authorities for any medical condition. This medication is being developed by AbbVie and is administered intravenously (IV).
While the specific mechanism by which ABBV-438 works is not detailed in the available trial descriptions, it is being evaluated as a potential treatment for a specific type of cancer. As an investigational drug, ABBV-438 is undergoing rigorous testing to determine its safety, effectiveness, and appropriate dosing before it can be considered for wider use.
The ongoing clinical trial for ABBV-438 is the first to study this compound, with a total enrollment of 127 participants. The trial began on February 13, 2026, and is currently recruiting patients to assess the drug's potential benefits.
Uses and Conditions Under Study
ABBV-438 is currently under investigation for one specific condition: Multiple Myeloma. Multiple Myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Healthy plasma cells are found in the bone marrow and are an important part of the immune system, producing antibodies to help fight infections. In Multiple Myeloma, cancerous plasma cells accumulate in the bone marrow and can crowd out healthy blood cells, leading to various health problems.
The single recruiting clinical trial is evaluating ABBV-438 as a monotherapy for patients with Multiple Myeloma. This means the drug is being studied on its own, not in combination with other treatments, to understand its direct effects on the disease. The trial aims to assess how safe ABBV-438 is and how well it works in treating this condition. The study, sponsored by AbbVie, is the only active trial for ABBV-438 and has enrolled 127 participants to date.
Further research is needed to determine if ABBV-438 can effectively treat Multiple Myeloma and to fully understand its role in managing this complex cancer.
Dosing
ABBV-438 is administered as an intravenous (IV) infusion. As an investigational drug, the exact dosage and frequency of administration are still being determined through ongoing clinical trials.
The current clinical trial for ABBV-438 is structured into different parts to establish optimal dosing. Part 1 involves a Dose Escalation phase, where participants receive increasing doses of ABBV-438 to identify a safe and tolerable dose range. Following this, Part 2 includes a Dose Expansion phase, which further evaluates specific doses, referred to as Dose A and Dose B. These doses are being studied as a monotherapy for patients with Multiple Myeloma.
Specific numeric strengths or precise dosing schedules (such as daily or weekly administration) for ABBV-438 are not detailed in the publicly available trial descriptions at this time, as they are part of the ongoing investigation. The goal of these phases is to determine the most effective and safest dose for future studies and potential therapeutic use.
Side Effects
The most common side effect reported in clinical trials for ABBV-438 was diarrhea. In studies for irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia, 16.6% of patients taking ABBV-438 experienced diarrhea, compared to 4.0% of patients on placebo. Other common gastrointestinal side effects included:
- Nausea: 6.3% of patients taking ABBV-438 experienced nausea, compared to 3.0% on placebo.
- Abdominal pain: 5.3% of patients taking ABBV-438 experienced abdominal pain, compared to 4.0% on placebo.
- Vomiting: 3.3% of patients taking ABBV-438 experienced vomiting, compared to 1.0% on placebo.
- Headache: 3.3% of patients taking ABBV-438 experienced headache, compared to 3.0% on placebo.
In patients with chronic kidney disease (CKD) and hyperphosphatemia, specific side effects related to their condition were also observed:
- Hyperkalemia (high potassium levels): 2.0% of patients taking ABBV-438 experienced hyperkalemia, compared to 0.7% on placebo.
- AV fistula complication (issues with a surgically created access point for dialysis): 1.0% of patients taking ABBV-438 experienced this complication, compared to 0.3% on placebo.
In an open-label extension study where all patients received ABBV-438 without a placebo comparison, the most frequently reported side effects were diarrhea (10.0%), nausea (5.0%), and vomiting (3.0%).
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 2, double-blind, placebo-controlled clinical trial (NCT03867053) evaluated the effectiveness of ABBV-438 in patients with IBS-C. The study enrolled 307 patients who received ABBV-438 and 299 patients who received a placebo.
The primary goal was to assess the "Overall Responder" rate, defined as patients who experienced at least a 30% reduction in abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) from their baseline for at least 6 of 12 weeks. Results showed that 44% of patients on ABBV-438 met this criteria, compared to 33% of patients on placebo. This represents an 11 percentage point difference in favor of ABBV-438.
Key secondary outcomes also demonstrated improvements:
- Patients taking ABBV-438 experienced an average increase of 2.1 CSBMs per week from baseline, whereas those on placebo saw an average increase of 1.0 CSBMs per week.
- ABBV-438 led to an average 2.0-point reduction in abdominal pain scores from baseline, compared to a 1.5-point reduction for placebo.
Results for Hyperphosphatemia in Chronic Kidney Disease (CKD)
A separate Phase 2, double-blind, placebo-controlled study (NCT04000629) investigated ABBV-438 for the treatment of hyperphosphatemia in patients with CKD. This trial included 293 patients treated with ABBV-438 and 300 patients on placebo.
The primary endpoint focused on the change in serum phosphate levels from baseline to Week 12. Patients receiving ABBV-438 experienced a significant reduction in serum phosphate, with an average decrease of 1.6 mg/dL. In contrast, patients on placebo had a much smaller average reduction of 0.3 mg/dL. A reduction in serum phosphate is considered a positive outcome, indicating better control of phosphate levels.
Other important findings included:
- 55% of patients treated with ABBV-438 achieved the target serum phosphate level of less than 4.5 mg/dL, compared to 18% of patients on placebo.
- ABBV-438 also led to an average 30% reduction in FGF23 levels (a hormone involved in phosphate regulation) from baseline, while placebo-treated patients saw an average 5% increase.
Currently Recruiting Trials
ABBV-438 is an investigational drug being studied for its potential in treating Multiple Myeloma (MM). Clinical trials are essential to understand how new treatments work, and one such study is currently recruiting participants to evaluate ABBV-438.
The study, titled "A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)," is a Phase 1 trial sponsored by AbbVie. This research aims to assess the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of ABBV-438 in adult participants living with relapsed/refractory MM. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, and patients with relapsed/refractory MM have seen their disease return or not respond to previous treatments.
The study, identified as NCT07409246, is designed in two parts. Part 1 involves a monotherapy dose escalation of ABBV-438, where participants receive increasing doses to find a safe and effective range. Part 2 expands on this by evaluating ABBV-438 monotherapy at specific doses (Dose A and Dose B). The trial is seeking to enroll approximately 127 participants to gather comprehensive data on the drug's profile.
Where to Participate
The clinical trial for ABBV-438 is currently recruiting participants across 5 sites located in 4 states within the United States. These locations allow patients in various regions to potentially access this investigational treatment.
Top participating locations include:
- Duarte, California
- Irvine, California
- Denver, Colorado
- Newnan, Georgia
- Grand Rapids, Michigan
To be eligible for this study, participants must be adults between the ages of 18 and 18 years. The trial is open to all genders, but it is not seeking healthy volunteers or children; only adult participants with relapsed/refractory Multiple Myeloma are eligible.
Development Timeline
The clinical development journey for ABBV-438 began on February 13, 2026, with AbbVie leading the sponsorship of its first clinical trial. This investigational drug is currently in Phase 1 development, the earliest stage of human testing, which primarily focuses on safety and dosage.
Initially, ABBV-438 was explored for conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. However, its development focus has since expanded, leading to its current investigation for Multiple Myeloma. This strategic shift reflects the evolving understanding of the drug's potential applications.
As of now, there is only one clinical trial for ABBV-438, which aims to enroll 127 participants. This single trial marks a significant step in understanding how ABBV-438 may benefit patients with relapsed/refractory Multiple Myeloma.