Ulcerative ColitisPhase 1NCT04862741
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
A Phase 1 study testing NX-13 250mg IR, NX-13 500mg IR and NX-13 500mg MR in people with Ulcerative Colitis, run by Landos Biopharma Inc. at 31 sites in 2 countries.
Trial summary
This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- NX-13 250mg IR, NX-13 500mg IR and NX-13 500mg MR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 5 May 2021to 5 Oct 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;
- active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;
- baseline fecal calprotectin ≥ 250 μg/g;
- biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study;
- 5-aminosalicylates must be stable for ≥ 1 month prior to randomization.
Who cannot join
- Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD;
- a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma;
- history of or at imminent risk of colectomy;
- history of or current colonic dysplasia ;
- recent history (within 2 years prior to randomization) or current adenomatous colonic polyps;
- treatment with an immunosuppressant within 3 months of randomization;
- bacterial or parasitic pathogenic enteric infection;
- live virus vaccination within 1 month prior to screening.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States22 sites
Avant Research Associates, LLC
Austin, Texas, 78742
Galen Medical Group
Chattanooga, Tennessee, 37404
Optimed Research, LTD
Columbus, Ohio, 43235
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033
Biopharma Informatics, LLC
Houston, Texas, 77084
Avant Research Associates LLC
Huntsville, Alabama, 35802
I.H.S Health LLC
Kissimmee, Florida, 34741
Om Research LLC
Lancaster, California, 93534
Care Access
Lumberton, North Carolina, 28538
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
Valencia Medical and Research Center
Miami, Florida, 33165
Allameh Medical Corporation
Mission Viejo, California, 92691
Care Access
New York, New York, 10065
California Medical Research Associates, Inc.
Northridge, California, 91324
Care Access
Orlando, Florida, 32825
LinQ Research, LLC
Pearland, Texas, 77584
Gastroenterology Associates of Pensacola, P.A.
Pensacola, Florida, 32503
Care Access
Pottsville, Pennsylvania, 17901
Care Access Research, Salt Lake City
Salt Lake City, Utah, 84124
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Victoria Gastroenterology
Victoria, Texas, 77904
Clinical Research of California
Walnut Creek, California, 94598
Ukraine9 sites
Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.
Dnipro, 49005
Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76008
Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"
Kyiv, 02091
Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology
Kyiv, 03143
Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy
Kyiv, 04078
Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
Vinnytsia, 21018
Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology
Vinnytsia, 21029
Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM
Zaporizhzhya, 69121
Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council
Zhytomyr, 10002
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.
Read the detailed description
Following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the United States, Australia, New Zealand, and Moldova. Eligible subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) or placebo via a computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for UC.
Dosing will extend over a 28-day period at each dose level. Subjects will receive the first dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will self-administer IP at home once daily for the remaining dosing days. The study duration will be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).
- Conditions
- Ulcerative Colitis
- Being tested
- NX-13 250mg IR, NX-13 500mg IR, NX-13 500mg MR, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-13 250mg IRDrug
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
NX-13 500mg IRDrug
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
NX-13 500mg MRDrug
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
PlaceboDrug
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| NX-13 250mg IR | Experimental | Oral Receives: Drug: NX-13 250mg IR |
| NX-13 500mg IR | Experimental | Oral Receives: Drug: NX-13 500mg IR |
| NX-13 500mg MR | Experimental | Oral Receives: Drug: NX-13 500mg MR |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
Measured: 63 days
Secondary outcomes (7)
PK profile of NX-13 after multiple oral dose administration in subjects with active UC
NX-13 concentrations in plasma, colonic tissue biopsies, and feces
Measured: 63 days
PK Parameters - Time to maximum concentration (tmax);
NX-13 concentrations, time to maximum concentration
Measured: 63 days
PK Parameters- Maximum concentration (Cmax)
NX-13 concentrations, maximum concentration
Measured: 63 days
PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);
NX-13 concentrations, area under the concentration-time curve from time 0 to last measurable
Measured: 63 days
PK Parameters-Terminal half-life (t1/2)
NX-13 terminal half-life PK
Measured: 63 days
PK Parameters- clearance (CL);
NX-13 clearance PK
Measured: 63 days
PK Parameters- Vz, apparent volume of distribution during terminal phase.
NX-13 - Vz, apparent volume of distribution during terminal phase.
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start5 May 2021
- Primary completion17 Jun 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landos Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Lichtiger, MD, Study director, Landos Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862741
- Sponsor's protocol ID
- NX-13-1b
- Status last verified
- Feb 2023
- First submitted
- 10 Mar 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verstockt B, Vermeire S, Peyrin-Biroulet L, Mosig R, Feagan BG, Colombel JF, Siegmund B, Rieder F, Schreiber S, Yarur A, Panaccione R, Dubinsky M, Lichtiger S, Cataldi F, Danese S. The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study. J Crohns Colitis. 2024 May 31;18(5):762-772. doi: 10.1093/ecco-jcc/jjad192.
PubMed 37952114
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04862741
- Acronym / sponsor ID
- NX-13-1b
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Landos Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 28 Apr 2021 (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.
This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.
Detailed description
Following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the United States, Australia, New Zealand, and Moldova. Eligible subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) or placebo via a computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for UC.
Dosing will extend over a 28-day period at each dose level. Subjects will receive the first dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will self-administer IP at home once daily for the remaining dosing days. The study duration will be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NX-13 250mg IR | Experimental | Drug: NX-13 250mg IROral |
| NX-13 500mg IR | Experimental | Drug: NX-13 500mg IROral |
| NX-13 500mg MR | Experimental | Drug: NX-13 500mg MROral |
| Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;
- active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;
- baseline fecal calprotectin ≥ 250 μg/g;
- biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study;
- 5-aminosalicylates must be stable for ≥ 1 month prior to randomization.
Key exclusion criteria (8 listed)
- Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD;
- a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma;
- history of or at imminent risk of colectomy;
- history of or current colonic dysplasia ;
- recent history (within 2 years prior to randomization) or current adenomatous colonic polyps;
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 |
|---|---|---|
| NX-13 250mg IRSubjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo. | Drug | NX-13 250mg IR |
| NX-13 500mg IRSubjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo. | Drug | NX-13 500mg IR |
| NX-13 500mg MRSubjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo. | Drug | NX-13 500mg MR |
| PlaceboSubjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo. | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
Time frame: 63 days
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
7 secondary outcomes
PK profile of NX-13 after multiple oral dose administration in subjects with active UC
Time frame: 63 days
PK Parameters - Time to maximum concentration (tmax);
Time frame: 63 days
PK Parameters- Maximum concentration (Cmax)
Time frame: 63 days
PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);
Time frame: 63 days
PK Parameters-Terminal half-life (t1/2)
Time frame: 63 days
PK Parameters- clearance (CL);
Time frame: 63 days
PK Parameters- Vz, apparent volume of distribution during terminal phase.
Time frame: 63 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 37952114Verstockt B, Vermeire S, Peyrin-Biroulet L, Mosig R, Feagan BG, Colombel JF, Siegmund B, Rieder F, Schreiber S, Yarur A, Panaccione R, Dubinsky M, Lichtiger S, Cataldi F, Danese S. The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study. J Crohns Colitis. 2024 May 31;18(5):762-772. doi: 10.1093/ecco-jcc/jjad192.
- 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.
Simon Lichtiger, MD study director
Landos Biopharma Inc.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NX-13 250mg IR, NX-13 500mg IR and NX-13 500mg MR in people with Ulcerative Colitis, run by Landos Biopharma Inc. at 31 sites in 2 countries.
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 5 inclusion and 8 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Ukraine. 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 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?
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC) (time frame: 63 days). 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 NCT04862741, which also lists 1 linked publication.
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 15 Feb 2023.