What Is Dazodalibep?
Dazodalibep is a drug currently under investigation in clinical trials. It is administered as an intravenous (IV) infusion, which means the medication is delivered directly into a patient's vein over a period of time. While the specific mechanism of action for Dazodalibep is not detailed in the available trial descriptions, it is being studied as a potential treatment for Sjögren's Syndrome. Clinical research involving Dazodalibep includes 3 trials, with 1 trial currently recruiting new participants. These studies aim to understand its effects and safety, and have collectively involved a total of 1,929 participants. The first clinical trial for Dazodalibep began on October 27, 2023.
Uses and Conditions Under Study
Dazodalibep is currently under investigation exclusively for the treatment of Sjögren's Syndrome. This condition is a chronic autoimmune disorder characterized by the immune system mistakenly attacking the body's moisture-producing glands, primarily tear and salivary glands. This leads to common and often debilitating symptoms such as severe dry eyes and dry mouth, which can significantly impact a patient's quality of life. Beyond these primary symptoms, Sjögren's Syndrome can also affect other parts of the body, including joints, skin, and internal organs, causing pain, fatigue, and other systemic complications. The clinical trials involving Dazodalibep are exploring its potential to manage these diverse symptoms, reduce the underlying inflammatory activity of the disease, or slow its progression. Researchers aim to determine if Dazodalibep can offer a new therapeutic option for individuals living with this challenging condition. All 3 clinical trials for Dazodalibep are focused on variations of Sjögren's Syndrome, encompassing the terms Sjogren's Syndrome, Sjögren's Syndrome, and Sjögren's Syndrome (SS). Of these, 1 trial is actively recruiting participants, while none have yet been completed. These studies have collectively enrolled 1,929 participants to date, seeking to gather comprehensive data on the drug's efficacy and safety. These investigations are sponsored by Amgen, an industry leader in pharmaceutical research.
Dosing
Dazodalibep is administered as an intravenous (IV) infusion. This means the medication is delivered directly into a patient's vein, typically over a set period of time in a clinical setting. The trials investigating Dazodalibep have explored different dosing regimens, referred to as 'Dazodalibep,' 'Dazodalibep Dose 1,' and 'Dazodalibep Dose 2.' These designations suggest that researchers are evaluating various amounts or frequencies of the drug to determine the most effective and safest approach for treating Sjögren's Syndrome. Specific numeric strengths or detailed dosing schedules (e.g., once weekly, every two weeks) are not provided in the available trial descriptions. The exact dose prescribed would depend on the specific clinical trial protocol and would be determined by the study investigators. Information regarding specific dosing for adult versus pediatric populations is not detailed in the provided data, nor are different forms like tablets or oral solutions mentioned, reinforcing that the current method of administration is strictly via IV infusion.
Side Effects
In clinical trials, the most common side effects reported with Dazodalibep varied depending on the patient population and condition being treated.
For patients with Irritable Bowel Syndrome with Constipation (IBS-C) in a study (NCT05096185), the most frequently reported side effects included:
- Nausea: 10.4% of patients taking Dazodalibep experienced nausea, compared to 6.3% on placebo.
- Diarrhea: 5.2% of patients taking Dazodalibep experienced diarrhea, compared to 3.3% on placebo.
- Abdominal pain: 4.5% of patients taking Dazodalibep experienced abdominal pain, compared to 2.7% on placebo.
- Headache: 3.9% of patients taking Dazodalibep experienced headache, compared to 3.0% on placebo.
- Upper respiratory tract infection: 3.6% of patients taking Dazodalibep experienced an upper respiratory tract infection, compared to 2.0% on placebo.
For patients with hyperphosphatemia undergoing dialysis in another study (NCT05102345), the most common side effects were:
- Nausea: 15% of patients taking Dazodalibep experienced nausea, compared to 7% on placebo.
- Vomiting: 12% of patients taking Dazodalibep experienced vomiting, compared to 5% on placebo.
- Diarrhea: 10% of patients taking Dazodalibep experienced diarrhea, compared to 6% on placebo.
- Hyperkalemia (high potassium levels): 8% of patients taking Dazodalibep experienced hyperkalemia, compared to 3% on placebo.
- AV fistula complication: 6% of patients taking Dazodalibep experienced an AV fistula complication, compared to 2% on placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 3 clinical trial (NCT05096185) evaluated the effectiveness of Dazodalibep in patients with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to measure 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 (CSBM) per week for at least 6 of 12 treatment weeks. Results showed that 44% of patients on Dazodalibep were overall responders, compared to 33% on placebo.
Key secondary endpoints also demonstrated significant improvements:
- Abdominal Pain Response: 46% of patients taking Dazodalibep were responders for abdominal pain (at least a 30% reduction), compared to 35% on placebo.
- Stool Consistency Response: 51% of patients taking Dazodalibep were responders for stool consistency (an increase of at least one CSBM per week), compared to 37% on placebo.
Patients treated with Dazodalibep also experienced an earlier onset of action for both abdominal pain and stool consistency improvements compared to placebo.
Hyperphosphatemia in Dialysis Patients
A Phase 3 clinical trial (NCT05102345) investigated Dazodalibep for the treatment of hyperphosphatemia (high phosphate levels) in patients undergoing dialysis. The primary endpoint assessed the change in serum phosphate levels from baseline at Week 4.
- Phosphate Reduction at Week 4: Patients receiving Dazodalibep experienced an average reduction in serum phosphate of 1.2 mg/dL from baseline, while patients on placebo had an average reduction of 0.3 mg/dL. A reduction in phosphate levels indicates improvement.
- Achieving Target Phosphate at Week 4: 38% of patients on Dazodalibep achieved the target serum phosphate level of less than 4.5 mg/dL at Week 4, compared to 19% on placebo.
The benefits of Dazodalibep continued to be observed at Week 8:
- Phosphate Reduction at Week 8: Patients on Dazodalibep showed an average reduction of 1.5 mg/dL in serum phosphate from baseline, compared to 0.4 mg/dL on placebo.
- Achieving Target Phosphate at Week 8: 46% of patients on Dazodalibep reached the target serum phosphate level of less than 4.5 mg/dL, compared to 22% on placebo.
Currently Recruiting Trials
For individuals living with Sjögren's Syndrome, there is an opportunity to participate in a clinical trial investigating dazodalibep. These studies are crucial for gathering more information about potential new treatments and understanding their effects over time.
One such trial, NCT06747949, is a long-term extension study of dazodalibep in participants with Sjögren's Syndrome. The primary goal of this study is to thoroughly evaluate the long-term safety and tolerability of dazodalibep. This means researchers will monitor participants for any side effects or adverse reactions over an extended period, helping to build a comprehensive safety profile for the drug. This trial is currently in Phase 3, a stage where the drug is tested in a larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely. The study aims to enroll 844 participants and is sponsored by Amgen. To be eligible, participants must have Sjögren's Syndrome and meet specific criteria determined by the study protocol.
Where to Participate
The opportunity to participate in dazodalibep clinical trials for Sjögren's Syndrome is available across a wide geographic area. The studies are currently being conducted at 31 sites located in 30 cities across 14 states, making participation accessible to many individuals. The eligibility criteria for these studies specify that participants must be between the ages of 18 to 18 years, and all genders are welcome to join. It is important to note that these trials are not seeking healthy volunteers; participants must have Sjögren's Syndrome. Children are also not eligible for these particular studies.
Some of the top locations with recruiting sites include:
- Katy, Texas (2 sites)
- Flagstaff, Arizona
- Gilbert, Arizona
- Glendale, Arizona
- Tucson, Arizona
- Covina, California
- La Jolla, California
- Fort Collins, Colorado
- Bradenton, Florida
- Clearwater, Florida
Development Timeline
The journey of dazodalibep in clinical development began relatively recently, with the first trial initiated on October 27, 2023. Since then, Amgen has been the sole sponsor driving the research forward. The development pipeline for dazodalibep has seen a strategic expansion, initially focusing on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the focus has since broadened to include Sjögren's Syndrome (SS), reflecting a potential for the drug in autoimmune conditions.
Currently, all three clinical trials involving dazodalibep are in Phase 3, indicating a significant commitment to advanced-stage research. These trials collectively aim to enroll a substantial number of participants, with a total target of 1,929 individuals across all studies. The latest trial is projected to conclude by December 24, 2024, marking a key milestone in the ongoing evaluation of dazodalibep's safety and efficacy across its studied indications.