Ulcerative ColitisPhase 2NCT05785715
Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
A Phase 2 study testing NX-13 250mg and NX-13 750mg in people with Ulcerative Colitis, run by AbbVie at 35 sites in 4 countries.
Trial summary
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC). 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?
- NX-13 250mg and NX-13 750mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 24 Apr 2023to 30 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult subjects aged 18 to 75 years (inclusive)
- Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence
- Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline
- ES ≥ 2 within 14 days prior to randomization
- RBS ≥ 1.
Who cannot join
- Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
- Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
- Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
- Bacterial or parasitic pathogenic enteric infection;
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
Poland18 sites
ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
Bydgoszcz
Przychodnia Vitamed NFZ
Bydgoszcz
AmiCare Centrum Medyczne
Jelenia Góra
VITA LONGA Clinic - Katowice
Katowice
Krakowska Przychodnia FutureMeds
Krakow
AmiCare Sp. z o.o. Sp.k.
Lodz
Amicare Sp z o.o. S.K
Opoczno
Twoja Przychodnia Opolskie Centrum Medyczne
Opole
RiverMED Poradnie Specjalistyczne Poznań
Poznan
Endoskopia Sp. z o.o.
Sopot
Sonomed Sp. z o.o. Centrum Medyczne
Szczecin
Twoja Przychodnia Szczecińskie Centrum Medyczne
Szczecin
Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
Torun
H-T Centrum Medyczne
Tychy
Office of Jaroslaw Kierkus, Dr N Med
Warsaw
Centrum Diagnostyczno - Lecznicze Barska
Włocławek
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw
Zabobrze Centrum Medyczne
Wroclaw
United States11 sites
Digestive Health Center of Michigan
Chesterfield, Michigan, 48047
Digestive Health Associates of Texas-GI Alliance Research-Garland
Garland, Texas, 75044
Digestive Health Associates of Texas-GI Alliance
Mansfield, Texas, 76003
Miami Clinical Research
Miami, Florida, 33155
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Orlando Health, Inc.
Orlando, Florida, 32806
Texas Digestive Disease Consultants-GI Alliance Research
Southlake, Texas, 76092
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
GCP Clinical Research
Tampa, Florida, 33609
Clinical Research Institute of Michigan
Troy, Michigan, 48098
Italy5 sites
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan
Azienda Ospedaliera - Universitaria Sant' Andrea
Roma
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano
IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
San Giovanni Rotondo
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
Read the detailed description
This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis
- Being tested
- NX-13 250mg, NX-13 750mg, NX-13 Placebo
- Keywords
- ulcerative colitis, moderate, severe
- Medical subject headings
- Colitis, Ulcerative, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-13 250mgDrug
NX-13 250mg tablet, plus 2 placebo tablets
NX-13 750mgDrug
NX-13 250mg tablets times 3 to equal 750mg
NX-13 PlaceboDrug
NX-13 Placebo tablets times 3 for blinding purposes
| Study group | Role | What they receive |
|---|---|---|
| NX-13 250mg | Experimental | Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. Receives: Drug: NX-13 250mg |
| NX-13 750mg | Experimental | Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. Receives: Drug: NX-13 750mg |
| NX-13 Placebo | Placebo comparator | Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. Receives: Drug: NX-13 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Mayo Score (MMS) at Week 12
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency [SFS], rectal bleeding [RBS] and finding on endoscopy [ES]), each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. A negative change in MMS score indicates improvement.
Measured: Baseline, Week 12
Secondary outcomes (15)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
Treatment-emergent adverse events (TEAEs) were defined as AEs that occurred after the participant received first dose of study treatment or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment until 21 days after the date and time of last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
Measured: Baseline up to Week 12
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
Measured: Baseline up to Week 12
Number of Participants With Clinical Remission Per MMS at Week 12
Clinical Remission per MMS was defined as achieving MMS <=2, with RBS =0, SFS <=1 and not greater than baseline, and ES <=1.
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status.
Measured: Week 12
Number of Participants With MMS <=2 at Week 12
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status.
Measured: Week 12
Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
The Robarts Histopathology Index (RHI) score is used to assess the disease severity. The RHI is defined as the sum of four weighted items from Geboes: Grade 1: lamina propria chronic inflammation; Grade 2B: lamina propria neutrophils; Grade 3: epithelial neutrophils; Grade 5: surface epithelial injury. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity) with a higher score indicating more severity.
Measured: Week 12
Number of Participants With Clinical Response Per MMS at Week 12
Clinical Response was defined as >=2 Points and >=30% decrease from baseline in MMS with >=1 point decrease in RBS or RBS <=1.
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Measured: Baseline, Week 12
Number of Participants With Endoscopic Response at Week 12
Endoscopic Response was defined as ES <=1.
The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Measured: Week 12
Number of Participants With Endoscopic Remission at Week 12
Endoscopic Remission was defined as ES =0.
The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Measured: Week 12
Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
Endoscopic-histologic Mucosal Improvement was defined as ES <=1 and Geboes score <2.0.
The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Measured: Week 12
Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
HEMI was defined as ES <=1 and Geboes score <3.1.
The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Measured: Week 12
Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
HEMR was defined as ES = 0 and Geboes score <2.0.
The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Measured: Week 12
Number of Participants With Symptomatic Remission at Week 12
Symptomatic remission was defined as RBS = 0 and (i) SFS = 0 or (ii) SFS = 1 with baseline SFS >2, at Week 12.
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Measured: Baseline, Week 12
Number of Participants With Clinical Response Per Partial MMS at Week 4
Clinical response per partial MMS was defined as achieving >=1 points and >=30% decrease from baseline in partial MMS, with >=1 point decrease in RBS or RBS <=1.
Partial MMS ranges from 0 (normal or inactive disease) to 6 (severe disease) and is calculated as the sum of 2 subscores (SFS and RBS), each of which ranges from 0 (normal) to 3 (severe disease). A lower partial MMS indicates better health status.
Measured: Baseline, Week 4
Number of Participants With Abdominal Pain Score = 0 at Week 12
Participants rated their abdominal pain on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more pain.
Measured: Week 12
Number of Participants With Rectal Urgency Score = 0 at Week 12
The rectal urgency score is based on the number of times participants must rush to the toilet to have a bowel movement. The score ranges from 0 (2 or fewer events) to 10 (12 or more events), with higher scores representing more severe symptoms.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start24 Apr 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Sponsor Decision\_Not Safety Related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785715
- Sponsor's protocol ID
- NX-13-201
- Status last verified
- May 2026
- First submitted
- 13 Feb 2023
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05785715
- Acronym / sponsor ID
- NX-13-201
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, moderate, severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision\_Not Safety Related
- Enrolment
- 81 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
Detailed description
This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NX-13 250mg | Experimental | Drug: NX-13 250mgSubjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. |
| NX-13 750mg | Experimental | Drug: NX-13 750mgSubjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. |
| NX-13 Placebo | Placebo comparator | Drug: NX-13 PlaceboSubjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects aged 18 to 75 years (inclusive)
- Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence
- Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline
- ES ≥ 2 within 14 days prior to randomization
- RBS ≥ 1.
Key exclusion criteria (5 listed)
- Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
- Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
- Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
- Bacterial or parasitic pathogenic enteric 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 |
|---|---|---|
| NX-13 250mgNX-13 250mg tablet, plus 2 placebo tablets | Drug | NX-13 250mg |
| NX-13 750mgNX-13 250mg tablets times 3 to equal 750mg | Drug | NX-13 750mg |
| NX-13 PlaceboNX-13 Placebo tablets times 3 for blinding purposes | Drug | NX-13 Placebo |
Primary outcome
Change From Baseline in Modified Mayo Score (MMS) at Week 12
Time frame: Baseline, Week 12
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency [SFS], rectal bleeding [RBS] and finding on endoscopy [ES]), each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. A negative change in MMS score indicates improvement.
15 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
Time frame: Baseline up to Week 12
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
Time frame: Baseline up to Week 12
Number of Participants With Clinical Remission Per MMS at Week 12
Time frame: Week 12
Number of Participants With MMS <=2 at Week 12
Time frame: Week 12
Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
Time frame: Week 12
Number of Participants With Clinical Response Per MMS at Week 12
Time frame: Baseline, Week 12
Number of Participants With Endoscopic Response at Week 12
Time frame: Week 12
Number of Participants With Endoscopic Remission at Week 12
Time frame: Week 12
Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
Time frame: Week 12
Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
Time frame: Week 12
Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
Time frame: Week 12
Number of Participants With Symptomatic Remission at Week 12
Time frame: Baseline, Week 12
Number of Participants With Clinical Response Per Partial MMS at Week 4
Time frame: Baseline, Week 4
Number of Participants With Abdominal Pain Score = 0 at Week 12
Time frame: Week 12
Number of Participants With Rectal Urgency Score = 0 at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
AbbVie study director
AbbVie
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NX-13 250mg and NX-13 750mg in people with Ulcerative Colitis, run by AbbVie at 35 sites in 4 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 5 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: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Poland, United States, Italy, Belgium. 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 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?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Modified Mayo Score (MMS) at Week 12 (time frame: Baseline, Week 12). 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 15 Jun 2026.