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Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT04862741
Recruitment Status : Not yet recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

Brief 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 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: NX-13 250mg IR Drug: NX-13 500mg IR Drug: NX-13 500mg MR Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Estimated Study Start Date : April 30, 2021
Estimated Primary Completion Date : June 12, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NX-13 250mg IR
Oral
Drug: NX-13 250mg IR
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.

Experimental: NX-13 500mg IR
Oral
Drug: NX-13 500mg IR
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.

Experimental: NX-13 500mg MR
Oral
Drug: NX-13 500mg MR
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.

Placebo Comparator: Placebo
Oral
Drug: Placebo
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. PK profile of NX-13 after multiple oral dose administration in subjects with active UC [ Time Frame: 63 days ]
    - NX-13 concentrations in plasma, colonic tissue biopsies, and feces

  2. PK Parameters - Time to maximum concentration (tmax); [ Time Frame: 63 days ]
  3. PK Parameters- Maximum concentration (Cmax) [ Time Frame: 63 days ]
  4. PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast); [ Time Frame: 63 days ]
  5. PK Parameters-Terminal half-life (t1/2) [ Time Frame: 63 days ]
  6. PK Parameters- clearance (CL); [ Time Frame: 63 days ]
  7. PK Parameters- Vz, apparent volume of distribution during terminal phase. [ Time Frame: 63 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862741


Contacts
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Contact: Jyoti Chauhan 5402182232 jyoti@landosbiopharma.com
Contact: Josep Bassaganya-Riera jbr@landosbiopharma.com

Sponsors and Collaborators
Landos Biopharma Inc.
Investigators
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Study Director: Jyoti Chauhan Landos Biopharma Inc.
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Responsible Party: Landos Biopharma Inc.
ClinicalTrials.gov Identifier: NCT04862741    
Other Study ID Numbers: NX-13-1b
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases