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Ulcerative Colitis (UC)Phase 2NCT06725017

A Phase 2 Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Adult Patients with Active Mild to Moderate Ulcerative Colitis

A Phase 2 study testing Live SK08 powder in people with Ulcerative Colitis (UC), run by Guangzhou Zhiyi Biotechnology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to preliminarily evaluate the efficacy and safety of SK08 in adult patients with active mild to moderate UC. Each subject will undergo three study periods: screening, induction treatment period and a safety follow-up period. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Live SK08 powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 1 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Subjects who voluntarily sign the informed consent form and are able to comply with the study protocol and have the ability to follow relevant procedures.
  • Male and female subjects aged 18-75 years (inclusive) at the time of signing the informed consent.
  • Ulcerative colitis diagnosed by routine clinical, endoscopy, and pathologic criteria for at least 3 months.
  • Subjects with active mild to moderate UC as defined by modified Mayo Score (mMS) of 4-10 (both inclusive), including an endoscopy sub-score of at least 2 and a rectal bleeding sub-score of at least 1.
  • The lesion extends beyond the rectum (colonoscopy shows that the lesion is > 15 cm from the anal verge).
  • Have had no response to, an inadequate response to, or an intolerance to standard 5-ASA treatment (including 5-ASA local treatment), no response or inadequate response means patients have persistent symptoms during treatment with 5-ASA at the recommended dose and treatment duration, intolerance means patients discontinue the 5-ASA treatment due to adverse events. Subjects receiving concurrent stable dose 5-ASA (i.e. no change in medication within 4 weeks of study enrollment and is not expected to change during the study) are permitted to be enrolled.
  • If female, the subject is non-lactating, and is either: Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; Of childbearing potential and is practicing at least 1 highly effective method of birth control including the barrier method; oral or parenteral contraceptives; a vasectomized partner; or abstinence from sexual intercourse from the time of signing informed consent and until at least 3 months after the last dose of the study drug. The Investigator will discuss with the subject the option of practicing more than 1 of the above methods for the duration of the study. Subjects must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug.
  • If male and partner is of childbearing potential, the subject agrees to practice at least one highly effective method of birth control from the time of signing the informed consent until at least 3 months after the last dose of the study drug.

Who cannot join

  • Subjects with Crohn's disease, radiation colitis, diverticulitis, ischemic colitis, microscopic colitis, drug-related (e.g., NSAIDs, tretinoin, immune checkpoint inhibitors, mycophenolate, etc.) colitis, patients with indeterminate colitis, and patients with endoscopy/biopsy showing ileitis/granulomas with clinical suspicion of Crohn's disease.
  • Malignancy or history of malignancy within the previous 5 years except for resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence.
  • Subjects who received surgery within 30 days before the first dose of study drug or who plan to undergo surgery during the study.
  • Subjects with other pathological conditions in the intestine, including colon dysplasia, intestinal stricture, tumor, intestinal fistula, intestinal obstruction, celiac disease, etc.
  • Presence of any active or chronic recurrent infections.
  • Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy).
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  • Subjects with severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, immune, cardiovascular, respiratory, neurological, or psychiatric disease.
  • Subjects with poor concurrent medical risks with a clinically significant co-morbid disease such that, in the opinion of the Investigator, the subject should not be enrolled including: Subjects with decompensated liver cirrhosis (Child-Pugh Class B or C) or uncontrolled liver disease; History of pancreatitis; QTc > 450 msec or QTc > 480 msec for participants with bundle branch block at screening and Day 1. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF); Prior history of bone marrow transplant; Known Hypogammaglobulinemia; Known severe immunodeficiency; AST ≥ 2 × the upper limit of normal (ULN) and/or ALT ≥ 2 × ULN and/or total bilirubin ≥ 2 × ULN; eGFR < 60 mL/min/1.73 m² by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation; Absolute neutrophil count (ANC) < 500 cells/μL.
  • Subjects with anti-hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, or hepatitis B surface antigen (HBsAg) positive and need antiviral therapy during the screening period.
  • Subjects have known or suspected hypersensitivity to the study drug and its excipients (maltodextrin, silicon dioxide, magnesium stearate).
  • Subjects who cannot discontinue steroid hormones (such as budesonide multi-matrix (MMX)) oral/topical (suppositories, enemas, etc.), or systemic corticosteroids within 2 weeks before the first dose of study drug.
  • Patients who cannot discontinue other drugs that affect gastrointestinal function, including systemic antibiotics, anti-diarrheal agents, etc., within 2 weeks before the first dose of study drug.
  • Received any probiotic medicines or fecal bacteria transplant within 30 days prior to the first dose.
  • Received treatment with biological agents (infliximab, adalimumab, golimumab, certolizumab, vedolizumab, ustekinumab, natalizumab, etc.) within 8 weeks before the first dose (or 5 half lives of the drug); or received any non-biological agents (cyclosporine, tacrolimus, thalidomide, methotrexate, tofacitinib, etc.) treatment within 30 days before the first dose (or 5 half-lives of the drug).
  • Received (attenuated) live vaccination within 4 weeks of Day 1 or plan to receive during the study until follow-up.
  • Subjects who have participated in any clinical trial within 3 months before screening.
  • Subjects with a history of alcohol and drug abuse.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yangyang Liu, MD contact

China: 020-82515346

liuyangyang@zypharm.com.cn

About this study

Official title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroides Fragilis) in Adult Patients with Active Mild to Moderate Ulcerative Colitis

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to preliminarily evaluate the efficacy and safety of SK08 in adult patients with active mild to moderate UC. Each subject will undergo three study periods: screening, induction treatment period and a safety follow-up period.

Being tested
Live SK08 powder, Placebo
Keywords
Ulcerative Colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Live SK08 powderDrug

    SK08 is an investigational live biotherapeutic product containing a nontoxigenic B. fragilis(NTBF) strain as an active ingredient.

  • PlaceboDrug

    Placebo

Study groups in NCT06725017
Study groupRoleWhat they receive
SK08 low dose groupExperimental1 × 10^7 CFU ~ 2.5 × 10^8 CFU/dose, twice daily (BID), taken orally for 8 weeks
Receives: Drug: Live SK08 powder
SK08 high dose groupExperimental1 × 10^9 CFU ~ 2.5 × 10^10 CFU/dose, BID, taken orally for 8 weeks
Receives: Drug: Live SK08 powder
Placebo groupPlacebo comparatorBID, taken orally for 8 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Proportion of subjects achieving clinical remission at Week 8

    Clinical remission is defined as a total mMS score of 0 to 2, including the following three components:

    • Stool frequency sub-score = 0 or 1.
    • Rectal bleeding sub-score = 0
    • Centrally read endoscopy sub-score = 0 or 1 (score of 1 modified to exclude friability)

    Measured: 0-8 weeks

Secondary outcomes (5)

  1. proportion of subjects with clinical response at Week 8

    Clinical response is defined as a decrease from baseline in the total mMS of ≥ 2 points and at least a 30 percent reduction from baseline, and a decrease in rectal bleeding subs-core of greater than or equal to 1 or an absolute rectal bleeding sub-score of 0 or 1.

    Measured: 0-8 weeks

  2. proportion of subjects with endoscopic improvement at Week 8

    Endoscopic improvement is defined as a centrally read endoscopy sub-score of 0 or 1.

    Measured: 0-8 weeks

  3. proportion of subjects with endoscopic remission at Week 8

    Endoscopic remission is defined as a centrally read endoscopy sub-score of 0.

    Measured: 0-8 weeks

  4. change from baseline in the total modified Mayo Score at Week 8

    Measured: 0-8 weeks

  5. mean change in rectal bleeding and stool frequency sub-scores from baseline to Weeks 2, 4, 6 and 8

    Measured: 0-2, 0-4, 0-6, 0-8 weeks

Timeline

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

  1. First posted9 Dec 2024
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

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
randomized, double-blind, placebo-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725017
Sponsor's protocol ID
SK08UC-201
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Live SK08 powder in people with Ulcerative Colitis (UC), run by Guangzhou Zhiyi Biotechnology Co., Ltd..

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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yangyang Liu, MD (China: 020-82515346, liuyangyang@zypharm.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving clinical remission at Week 8 (time frame: 0-8 weeks). 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 NCT06725017.

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 16 Dec 2024.

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