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Ulcerative ColitisPhase 2NCT06398808

A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

A Phase 2 study testing Arm1 and Arm 2 in people with Ulcerative Colitis, run by Zydus Lifesciences Limited at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Arm1 and Arm 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteIndia
Study dates
8 Apr 2024to 28 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 18 to 75 years, both inclusive.
  • Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
  • Mild to Moderate active disease defined as total score of at least 4 on the mMS, endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least 1.
  • Demonstrated an inadequate response to, loss of response to, or intolerance to any of the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide)
  • ○ Signs and symptoms of persistently active disease, in the opinion of the investigator, during a current or prior course of at least 4 weeks of treatment with 2.4 g/day mesalamine, 4 g/day sulfasalazine, 1 g/day olsalazine, or 6.75 g/day balsalazide.
  • Have undergone colonoscopy within the past 2 years for extent of disease, and if the UC has been present for > 10 years, have had a colonoscopy with biopsy to rule out dysplasia
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  • Patients who meet following laboratory values (assessed within 28 days prior to randomization):
  • WBCs ≥2000/μL
  • Neutrophils ≥1500/μL
  • Platelets ≥100 X 10³/μL
  • Hemoglobin ≥8.5 g/dL
  • Serum creatinine of ≤1.5 X ULN or creatinine clearance >40 mL/minute (using Cockcroft/Gault formula)
  • AST \& ALT ≤1.5 X ULN
  • Total bilirubin ≤ 1.5 X ULN
  • Men and women of childbearing potential must agree to use adequate birth control measures during the study. Acceptable methods of birth control in this study include: surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence for at least 4 weeks prior to study drug administration, during study participation and for 30 days after their last dose of study drug.
  • All patients aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of screening or must have had a colonoscopy at screening to assess for polyps.
  • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments. In case of illiterate patients, thumb impression of the patients will be obtained along with the signature of the impartial witness or legally authorized representative (LAR) on the consent form prior to patient's participation in the trial.

Who cannot join

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease.
  • Have severe extensive colitis as evidenced by at least one of the following:
  • Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
  • Current evidence of fulminant colitis, toxic megacolon or bowel perforation.
  • Previous total colectomy
  • Have 4 or more of the following i.e Body temperature > 38 C,HR > 110 (bpm),Focal severe or rebound abdominal tenderness,Anemia (hemoglobin [Hgb] < 8.5 g/dL), Transverse colon diameter > 5 cm on plain X-ray.
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  • Have positive stool culture for pathogens (O P, bacteria) or positive test for C.
  • difficile at screening. If C. difficile is positive, the patient may be treated and retested.
  • Patients who have an evidence of pathogenic bowel infection.
  • History of recurrent or chronic infection (e.g. hepatitis B or C, syphilis, TB).
  • Laboratory test positive for HBsAg, HCV or HIV at screening.
  • Have had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 16 weeks of screening.
  • History or planned concurrent treatment with biological agents (infliximab, adalimumab, vedolizumab, and ustekinumab), immunosuppressive agents (e.g., azathioprine, 6-MP, or methotrexate) or with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab), Janus kinase (JAK) inhibitor (e.g.,Tofacitininb), steroids (e.g., prednisolone) prior to randomization.
  • History of treatment with an investigational agent within 5 half-lives of that agent prior to randomization.
  • History of treatment with topical rectal 5-ASA or steroids within 2 weeks of screening.
  • Receipt of a live vaccine within 4 weeks prior to randomization.
  • Chronic use of therapies that strongly inhibit or induce CYP3A4 metabolism within 4 weeks prior to randomization.
  • Clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the patient at risk by participating in the study.
  • Pregnant or lactating women or women of child bearing potential who have positive serum beta HCG test at screening.
  • History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
  • History of difficulty with donating blood
  • Participants who have participated in any drug research study other than the present trial within past 3 months
  • Patients that have undergone significant trauma or major surgery within 4 weeks of screening visit.

Trial locations and contacts

1 site in 1 country.

India1 site

  • ICON Hospital

    Ahmedabad, Gujarat, 380015

Other trials in India

About this study

Official title: A Randomised, Double Blind, Parallel, Interventional Phase IIa Proof of Concept Trial to Evaluate the Efficacy and Safety of ZYIL1 for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.

Read the detailed description

This is a Phase IIa, randomized, two arms, double blind, double dummy, parallel, multicentre study to evaluate efficacy and safety of ZYIL1 oral capsules for the treatment of mild to moderately active ulcerative colitis resistant or intolerant to oral aminosalicylates.

The study consists

The study consists of: screening period of upto 4 weeks, treatment period of 12 weeks (first 6 weeks period: Induction period and remaining 6 weeks: Maintenance period), and end of the study at Week 13. The total duration of the study will be 119 days including screening period of 28 days.

Being tested
Arm1, Arm 2
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm1Drug

    ZYIL1 capsules 25 mg for oral administration + 50 mg placebo

  • Arm 2Drug

    ZYIL1 capsules 50 mg for oral administration + 25 mg placebo

Study groups in NCT06398808
Study groupRoleWhat they receive
Arm 1 (ZYIL1 capsules & placebo)Active comparatorZYIL1 capsules 25 mg for oral administration + 50 mg placebo
Receives: Drug: Arm1
Arm 2 (ZYIL1 capsules & placebo)Active comparatorZYIL1 capsules 50 mg for oral administration + 25 mg placebo
Receives: Drug: Arm 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the efficacy of ZYIL1 for induction of clinical remission

    clinical remission defined as an mMS score of 0 to 2, including: stool frequency subscore 0 or 1, rectal bleeding subscore 0 and endoscopy score 0 or 1.

    mMS;modified Mayo Score Minimum value "0" and Maxium Value "9" Higher scores means worse outcome compare to baseline.

    Measured: Baseline to week 6

Secondary outcomes (4)

  1. Proportion of participants achieving clinical response

    Clinical Response defined decrease from baseline* in the mMS of greater than or equal to 2 points

    mMS;modified Mayo Score Minimum value "0" and Maxium Value "9" Higher scores means worse outcome compare to baseline.

    Measured: Week 6 and Week 12

  2. Proportion of participants in clinical remission

    clinical remission defined as an mMS score of 0 to 2, including: stool frequency subscore 0 or 1, rectal bleeding subscore 0 and endoscopy score 0 or 1.

    mMS;modified Mayo Score Minimum value "0" and Maxium Value "9" Higher scores means worse outcome compare to baseline.

    Measured: Week 12

  3. Proportion of participants in endoscopic remission

    Measured: Week 6 and Week 12

  4. Mean change in biomarker fecal calprotectin

    Measured: Baseline to Week 6 & Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start8 Apr 2024
  3. Primary completion22 Nov 2024
  4. Study completion28 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomly assigned in a 1:1 ratio
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398808
Sponsor's protocol ID
ZYIL1.23.001
Status last verified
Dec 2024
First submitted
8 Feb 2024
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm1 and Arm 2 in people with Ulcerative Colitis, run by Zydus Lifesciences Limited at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of ZYIL1 for induction of clinical remission (time frame: Baseline to week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06398808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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