Ulcerative ColitisPhase 1NCT06260267
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
A Phase 1 study testing Microbiota suspension and Microbiota capsule in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 10 sites in United States.
Trial summary
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Microbiota suspension and Microbiota capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Mar 2024to 15 Jan 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged ≥18 at screening
- Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening
Who cannot join
- Active disease or history of Crohn's disease
- Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
- Active gastrointestinal infection.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ferring Investigational Site
Boston, Massachusetts, 02115
Ferring Investigational Site
Glenview, Illinois, 60026
Ferring Investigational Site
Gurnee, Illinois, 60031
Ferring Investigational Site
Hamden, Connecticut, 06518
Ferring Investigational Site
Inverness, Florida, 34452
Ferring Investigational Site
Jacksonville, Florida, 32256
Ferring Investigational Site
North Little Rock, Arkansas, 72117
Ferring Investigational Site
Oklahoma City, Oklahoma, 73102
Ferring Investigational Site
Orange City, Florida, 32763
Ferring Investigational Site
Shreveport, Louisiana, 71105
About this study
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis
- Being tested
- Microbiota suspension, Microbiota capsule, Placebo suspension, Placebo capsule
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota suspensionDrug
Microbiota suspension
Microbiota capsuleDrug
Microbiota capsule
Placebo suspensionDrug
Placebo suspension
Placebo capsuleDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| FE 999322 | Experimental | Microbiota suspension Receives: Drug: Microbiota suspension |
| FE 999324 | Experimental | Microbiota capsule Receives: Drug: Microbiota capsule |
| Placebo FE 999322 | Placebo comparator | Placebo suspension Receives: Drug: Placebo suspension |
| Placebo FE 999324 | Placebo comparator | Placebo capsule Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events from baseline to week 52
Measured: From baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start12 Mar 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Why it stopped: Not due to safety concerns, but changes in strategy which this trial no longer fulfills.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260267
- Sponsor's protocol ID
- 000417
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06260267
- Acronym / sponsor ID
- 000417
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not due to safety concerns, but changes in strategy which this trial no longer fulfills.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FE 999322 | Experimental | Drug: Microbiota suspensionMicrobiota suspension |
| FE 999324 | Experimental | Drug: Microbiota capsuleMicrobiota capsule |
| Placebo FE 999322 | Placebo comparator | Drug: Placebo suspensionPlacebo suspension |
| Placebo FE 999324 | Placebo comparator | Drug: Placebo capsulePlacebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject aged ≥18 at screening
- Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening
Key exclusion criteria (3 listed)
- Active disease or history of Crohn's disease
- Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
- Active gastrointestinal infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota suspensionMicrobiota suspension | Drug | FE 999322 |
| Microbiota capsuleMicrobiota capsule | Drug | FE 999324 |
| Placebo suspensionPlacebo suspension | Drug | Placebo FE 999322 |
| Placebo capsulePlacebo capsule | Drug | Placebo FE 999324 |
Primary outcome
Treatment-emergent adverse events from baseline to week 52
Time frame: From baseline to week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microbiota suspension and Microbiota capsule in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 10 sites in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment-emergent adverse events from baseline to week 52 (time frame: From baseline to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.