A Phase II Study of ZX-408 Extended-Release Capsules for Moderately to Severely Active Ulcerative Colitis
This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) effects of ZX-408 Extended-Release Capsules during both the induction and maintenance treatment periods in patients with moderately to severely active ulcerative colitis (UC). The study consists of an up to 4-week screening period, a 12-week double-blind induction treatment period, a 40-week double-blind maintenance treatment period or open-label extension treatment period, and a 4-week safety follow-up period.
Study details:
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Efficacy and Safety of ZX-408 Extended-Release Capsules in Patients With Moderately to Severely Active Ulcerative Colitis (UC). Primary Purpose: Treatment. Allocation: Randomized.
Interventional Model: Parallel Assignment. Masking: Double (Participant, Investigator). Other Study ID Numbers: SLD-2025-ZX408-201.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Age ≥18 years to ≤70 years, regardless of gender
- Diagnosis of ulcerative colitis (UC) ≥12 weeks prior to screening, with endoscopic and histopathological evidence required for confirmation
- Moderately to severely active UC, defined as a total Mayo score of 6–12, with an endoscopic subscore ≥2, confirmed during the screening period
- Inadequate response, loss of response, or intolerance to one or more of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine), or advanced therapies (anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitors)
- If receiving concomitant medication for UC at screening, must be on a stable dose during the screening period and throughout the study as specified in the protocol
Exclusion criteria
- History of hypersensitivity to any component of the investigational product, including the active drug and placebo
- Diagnosis of Crohn's disease, indeterminate colitis, or evidence of toxic megacolon
- Use of biologic therapies (e.g., anti-TNF, anti-integrin, anti-IL-12/23) within 8 weeks prior to baseline or within 5 half-lives, whichever is longer
- Use of JAK inhibitors within 4 weeks prior to baseline
- Major gastrointestinal surgery within 6 months prior to screening
- Evidence of active or latent tuberculosis, or any clinically significant active infection
- Pregnant or breastfeeding women
- History of malignancy within the past 5 years, other than adequately treated basal cell carcinoma
- Total parenteral nutrition or fecal microbiota transplantation within 4 weeks prior to screening endoscopy
Eligibility
Age eligible for study : 18 Years to 70 Years
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start: 2026-08-15
Primary completion: 2026-12-15
Study completion finish: 2028-01-15
Study type
Drug
Phase
- Phase 2
Study ID
CARECO-337B5E58DD874
Intervention or treatment
Drug: ZX-408 Extended-Release Capsules Low-dose
Drug: ZX-408 Extended-Release Capsules High-dose
Drug: Placebo
Conditions
- Ulcerative Colitis
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Research sites nearby
Closest Location:
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Example Digestive Health Research Center
Columbus, Ohio, United States
Example Gastroenterology Clinical Institute
Austin, Texas, United States
Example Inflammatory Bowel Disease Centre
Hamilton, Ontario, Canada
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Who is running the clinical trial?
Solandra Therapeutics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental: ZX-408 ER Capsules Low-dose Group
| ZX-408 Extended-Release Capsules Low-dose |
Experimental: ZX-408 ER Capsules High-dose Group
| ZX-408 Extended-Release Capsules High-dose |
Placebo Comparator: Placebo Group
| Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving clinical remission based on Mayo score | Clinical remission defined per protocol | Week 12 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving clinical response based on Mayo score | Week 12 | |
| Proportion of participants achieving endoscopic improvement | Week 12 | |
| Proportion of participants achieving mucosal healing | Week 52 | |
| Change from baseline in partial Mayo score | Week 12 |
References
Clinical Trials Gov: A Phase II Study of ZX-408 Extended-Release Capsules for Moderately to Severely Active Ulcerative ColitisOther trials to consider
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