What the trial was testing
The VEGA enrolled 214 patients with ulcerative colitis. The study was sponsored by Janssen Research & Development, LLC and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
83% of patients on the combination therapy improved after 12 weeks, compared to 61% on one drug alone.
The lancet. Gastroenterology & hepatology · 2023 · NCT03662542
These findings — that patients on two antibodies together had better symptom relief than those on one drug — were published in the The lancet. Gastroenterology & hepatology and represent the headline result of the study.
Researchers tracked outcomes across 214 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with ulcerative colitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This mid-stage study tested combining two antibody injections for ulcerative colitis. The combination worked better than either drug alone, with more patients seeing reduced bleeding and inflammation. Neither treatment is FDA-approved as a combination yet. If you're struggling with current therapies, ask your doctor about combination approaches or open trials testing new options.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open ulcerative colitis trials
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics/Pharmacodynamics (PK/PD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort. week treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy. Dose Group Design: Group A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
The purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. The question that this study aims to answer is: When treating patients with moderate to severe ulcerative colitis, should IFX or VDZ be prioritized as the first-line choice for biologics?, Which biological agent has better therapeutic effect?. Researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.