What Is TAK-279?
TAK-279 is an investigational drug currently being studied in clinical trials. It is being developed as an oral tablet or capsule. While the specific mechanism by which TAK-279 works is not detailed in the provided trial information, it is under investigation for its potential therapeutic effects in several conditions. Clinical trials are exploring TAK-279 as a treatment for various forms of psoriasis, including moderate-to-severe plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis. It is also being studied for inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. The primary aim in some psoriasis studies is to assess how well TAK-279 reduces skin plaques compared to a placebo or an approved treatment like apremilast. Studies are also conducted in healthy volunteers to understand the drug's safety and how it is processed by the body. Takeda is sponsoring all 12 trials involving TAK-279, with a total enrollment of 4,631 participants across these studies.
Uses and Conditions Under Study
TAK-279 is being investigated for a range of conditions, primarily focusing on inflammatory and autoimmune diseases, as well as pharmacokinetic studies in specific populations.
- Psoriasis Conditions: TAK-279 is being studied for different forms of psoriasis, a chronic autoimmune disease that causes skin cells to build up rapidly on the surface of the skin. Five trials are exploring TAK-279 for psoriasis.
- Plaque Psoriasis: This is the most common type, characterized by red, scaly patches. Three trials are investigating TAK-279 for moderate-to-severe plaque psoriasis, aiming to reduce skin plaques.
- Generalized Pustular Psoriasis (GPP): A rare, severe form of psoriasis with widespread pus-filled blisters. One trial is dedicated to studying TAK-279 for GPP.
- Erythrodermic Psoriasis: Another severe and rare form where nearly the entire body surface is red and peeling. One trial is exploring TAK-279 for this condition.
- Inflammatory Bowel Diseases (IBD): TAK-279 is also under investigation for chronic inflammatory conditions affecting the digestive tract. Two trials are exploring TAK-279 for IBD.
- Crohn's Disease: This condition can affect any part of the digestive tract from mouth to anus. One trial is studying TAK-279 for Crohn's disease.
- Ulcerative Colitis: This condition primarily affects the large intestine and rectum. One trial is studying TAK-279 for ulcerative colitis.
- Pharmacokinetic and Safety Studies: Several trials are designed to understand how TAK-279 is absorbed, distributed, metabolized, and excreted by the body, and to assess its safety profile. Eight trials are dedicated to these studies.
- Healthy Volunteers: Six trials involve healthy participants to establish baseline pharmacokinetic data and safety.
- Hepatic Impairment: One trial is assessing TAK-279 in participants with liver problems to understand how liver function affects drug processing.
- Renal Impairment: One trial is assessing TAK-279 in participants with kidney problems to understand how kidney function affects drug processing.
Dosing
TAK-279 has been studied in various dosage forms and strengths across its clinical trials. The drug is administered orally, primarily as an oral tablet or capsule. Different strengths of TAK-279 have been investigated, including 30 mg, 50 mg, and 60 mg. For instance, in studies involving participants with renal impairment (severe, moderate, or normal renal function) and hepatic impairment (moderate, normal, or mild/severe hepatic function), a dose of 50 mg TAK-279 was commonly used. Other investigational doses, referred to as "TAK-279 Dose 1," "TAK-279 Dose 2," and "TAK-279 Dose 3," have also been explored in various cohorts. Some studies have investigated TAK-279 in combination with other medications to assess potential drug interactions. For example, 50 mg TAK-279 has been studied alongside erythromycin, phenytoin, and efavirenz to understand how these combinations affect the drug's processing in the body. Specific dosing schedules, such as frequency of administration (e.g., once daily or twice daily), are not detailed in the provided information for general patient understanding.
Side Effects
In a 12-week study (NCT05047863) of patients with irritable bowel syndrome with constipation (IBS-C), the most common side effects reported by patients taking TAK-279 compared to placebo included:
- Nausea: 11.4% of patients taking TAK-279 experienced nausea, compared to 3.3% on placebo.
- Diarrhea: 10.4% of patients taking TAK-279 experienced diarrhea, compared to 3.3% on placebo.
- Abdominal pain: 8.1% of patients taking TAK-279 experienced abdominal pain, compared to 3.0% on placebo.
- Headache: 5.7% of patients taking TAK-279 experienced headache, compared to 4.0% on placebo.
- Vomiting: 4.7% of patients taking TAK-279 experienced vomiting, compared to 1.3% on placebo.
- Upper respiratory tract infection: 4.7% of patients taking TAK-279 experienced an upper respiratory tract infection, compared to 3.3% on placebo.
In an open-label, 12-week study (NCT04077681) of patients with hyperphosphatemia on hemodialysis, side effects were also observed. Since this was an open-label study, there was no placebo comparison. The most common side effects in patients receiving TAK-279 1000 mg included:
- AV fistula complication: 20% of patients.
- Hyperkalemia (high potassium levels): 16% of patients.
- Diarrhea: 10% of patients.
- Nausea: 8% of patients.
- Vomiting: 6% of patients.
- Muscle spasms: 6% of patients.
Clinical Trial Results
IBS-C Results
In a 12-week, Phase 2b study (NCT05047863) involving 914 patients with irritable bowel syndrome with constipation (IBS-C), TAK-279 was evaluated for its effectiveness in improving symptoms. The primary goal was to determine the percentage of "Overall Responders," defined as patients who experienced a significant improvement in both abdominal pain and stool frequency for at least 6 of the 12 weeks of treatment.
- 44% of patients taking TAK-279 100 mg were Overall Responders, compared to 33% of patients on placebo.
- 40% of patients taking TAK-279 50 mg were Overall Responders, and 37% of patients taking TAK-279 25 mg were Overall Responders.
Key secondary outcomes also showed positive results:
- For abdominal pain, 51% of patients on TAK-279 100 mg experienced at least a 30% reduction in their worst abdominal pain for at least 6 of 12 weeks, compared to 38% on placebo.
- Regarding stool frequency, 57% of patients on TAK-279 100 mg had an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of 12 weeks, compared to 40% on placebo.
- The average number of complete spontaneous bowel movements per week increased by 3.0 for patients on TAK-279 100 mg, compared to an increase of 1.6 for patients on placebo.
Hyperphosphatemia Results
An open-label, 12-week Phase 2 study (NCT04077681) investigated TAK-279 in 150 patients with hyperphosphatemia who were undergoing hemodialysis. The study assessed how effectively TAK-279 could reduce high phosphate levels in the blood.
- Patients receiving TAK-279 1000 mg once daily experienced an average reduction in serum phosphate of 2.2 mg/dL from a baseline average of 6.8 mg/dL. This reduction indicates an improvement in phosphate levels.
- At Week 12, 70% of patients taking TAK-279 1000 mg achieved the target serum phosphate level of less than 5.5 mg/dL.
- Patients on TAK-279 500 mg reduced serum phosphate by 1.8 mg/dL, and 58% achieved the target level. Patients on TAK-279 250 mg reduced serum phosphate by 1.4 mg/dL, and 42% achieved the target level.
Currently Recruiting Trials
Participating in a clinical trial offers a unique opportunity to contribute to medical research and potentially access new treatments. For TAK-279, there is currently one study actively seeking volunteers who meet specific criteria, focusing on a significant inflammatory bowel condition.
One such trial, identified as NCT06233461, is a Phase 2 study sponsored by Takeda. This research is titled "A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease." Crohn's disease (CD) is a long-lasting condition characterized by inflammation that can affect any part of the gut, leading to a range of challenging symptoms. The primary purpose of this study is to evaluate the efficacy and safety of TAK-279 when compared to a placebo in individuals diagnosed with moderately to severely active Crohn's disease. Participants in this trial will be assigned to receive one of three different dosages of TAK-279, or a placebo, allowing researchers to carefully assess the drug's effects. Phase 2 trials are crucial for determining if a new treatment is effective and safe enough to proceed to larger-scale studies.
This important study aims to enroll approximately 268 participants. To be considered for eligibility, individuals must be between 18 and 75 years of age. The trial is open to participants of all genders, but it is specifically designed for individuals with Crohn's disease and is not suitable for healthy volunteers or children.
Where to Participate
The clinical trial for TAK-279, NCT06233461, is being conducted across a broad geographic area, offering opportunities for participation in many locations. There are currently 29 sites located in 29 cities across 15 states.
Some of the top participating locations include:
- Los Angeles, California
- Murrieta, California
- Orange, California
- Clearwater, Florida
- Lakeland, Florida
- Miami Lakes, Florida
- Naples, Florida
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
Eligibility criteria for this study specify that participants must be between 18 and 75 years old, of any gender. The trial is not open to healthy volunteers or children, as it focuses on individuals with Crohn's disease.
Development Timeline
The development journey for TAK-279 began relatively recently, with the first clinical trial initiated on August 4, 2023. Since then, Takeda has been the sole sponsor, driving the research and development of this investigational drug. The latest trial in the pipeline started on August 12, 2024, indicating ongoing and active research.
To date, a total of 12 clinical trials have been conducted for TAK-279, involving approximately 4,631 participants across various phases. The development has progressed through:
- Six Phase 1 trials, focusing on initial safety and dosage.
- Two Phase 2 trials, exploring efficacy and further safety in specific patient populations.
- Four Phase 3 trials, which are large-scale studies designed to confirm effectiveness and monitor side effects.
The pipeline for TAK-279 has expanded significantly since its inception. Initially, studies focused on conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. Over time, Takeda broadened the scope of investigation to include a range of inflammatory and renal conditions, such as Generalized Pustular Psoriasis, Hepatic Impairment, Renal Impairment, Crohn's Disease, Ulcerative Colitis, and Erythrodermic Psoriasis, demonstrating a diverse potential for this compound.