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Crohn's DiseasePhase 2SERENITYNCT02891226

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

A Phase 2 study testing Mirikizumab in people with Crohn's Disease, run by Eli Lilly and Company at 108 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
Mirikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
191 participants
Where
108 sitesin 14 countries
Study dates
14 Dec 2016to 5 Feb 2021
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

  • Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
  • Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

Who cannot join

  • Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
  • Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
  • Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
  • Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

Trial locations and contacts

108 sites in 14 countries.

108 sites in 14 countries

United States44 sites

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Consultants For Clinical Research

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • University Hospitals Health Center

    Cleveland, Ohio, 44106

  • Delta Waves Sleep Disorders and Research Center

    Colorado Springs, Colorado, 80918

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Valley View Internal Medicine

    Garden Grove, California, 92843

  • Gastro One

    Germantown, Tennessee, 38138

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06518

  • Wellness Clinical Research

    Hialeah Gardens, Florida, 33012

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004

  • Longwood Research

    Huntsville, Alabama, 35801

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Ocean State Clinical Research Partners

    Lincoln, Rhode Island, 02865

  • Robley Rex VAMC

    Louisville, Kentucky, 40206

  • University of Miami

    Miami, Florida, 33136

  • Vista Health Research

    Miami, Florida, 33176

  • Delta Research Partners LLC

    Monroe, Louisiana, 71201

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida, 32801

  • Health Quest Medical Care

    Owensboro, Kentucky, 42303

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Digestive Health Associates of Texas

    Richardson, Texas, 75082

  • MedStar Health Research Institute

    Rosedale, Maryland, 21237

  • Care Access Research - Salt Lake City

    Salt Lake City, Utah, 84124

  • San Antonio Gastroenterology

    San Antonio, Texas, 78229

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington Medical Center

    Seattle, Washington, 98195-6424

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

  • Washington University Medical School

    St Louis, Missouri, 63110

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85710

  • Healthcare Research Consultant

    Tulsa, Oklahoma, 74135

  • Advanced Gastroenterology

    Union City, Tennessee, 38261

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan13 sites

  • Tokyo Medical And Dental University Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818 8502

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • Kitakyushu Municipal Medical Center

    Kitakyusyu-shi, Fukoka, 802-0077

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Kinshukai Infusion Clinic

    Osaka, Osaka, 530-0011

  • Toho University School of Medicine, Sakura Hospital

    Sakura-shi, Chiba, 285 8471

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, 060 0033

  • Takagi Clinic

    Sendai, Miyagi, 981 3213

  • JHCO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Toyama Prefectural Central Hospital

    Toyama, Toyama, 930-8550

Other trials in Japan

Russia11 sites

  • Novosibirsk State Medical University

    Novosibirsk, 630091

  • FSBI Scientific Research Inst. of Physyology and Basic Medic

    Novosibirsk, 630117

  • Ultramed

    Omsk, 644024

  • City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral

    Perm, 614068

  • Private Medical Institution Evromedservis

    Pushkin, 196603

  • Baltic Medicine

    Saint Petersburg, 194356

  • City Hospital of Saint Martyr Elizabeth

    Saint Petersburg, 195257

  • LLC Scientific Research Centre EKO-Bezopasnost

    Saint Petersburg, 196143

  • Medical Institute REAVIZ

    Samara, 443001

  • NonState Healthcare Institution Central Clinical Hospital

    Samara, 443041

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

Other trials in Russia

Ukraine9 sites

  • Kyiv Municipal Clinical Hospital #1

    Kyiv, 02091

  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

    Kyiv, 04107

  • Lviv Regional Central Hospital

    Lviv, 79010

  • Odesa Regional Clinical Hospital

    Odesa, 65117

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88018

  • Vinnitsa City Clinical Hospital #1

    Vinnytsia, 21005

  • SRI of Invalid Rehabil.,Educ.Scient.Med.Complex

    Vinnytsia, 21030

  • City Clinical Hospital #6

    Zaporizhzhya, 69035

  • CI City Hospital #1

    Zaporizhzhya, 69104

Other trials in Ukraine

Poland7 sites

  • Szpital Uniwersytecki nr 2 im. dr J. Biziela

    Bydgoszcz, 85-168

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warsaw, 00-632

  • Melita Medical Sp. Z O. O.

    Wroclaw, 50-449

Other trials in Poland

Czechia6 sites

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 50012

  • Gregar s.r.o.

    Olomouc, 779 00

  • Fakultni Nemocnice v Motole

    Prague, 150 06

  • Thomayerova Nemocnice

    Praha 4 - Krc, 140 59

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, Czech Republic, 40113

  • Krajska nemocnice T. Bati a.s.

    Zlín, 76275

Other trials in Czechia

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Health Services - Base Hospital

    Ballarat, Victoria, 3350

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Netherlands4 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Radboud Universitair Medisch Centrum Nijmegen

    Nijmegen, 6525

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

  • St Elisabeth Ziekenhuis

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Romania3 sites

  • SC Med Life SA

    Bucharest, 010719

  • SC Pelican SRL

    Oradea, Bihor County, 410469

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timișoara, 300002

Other trials in Romania

Belgium2 sites

  • Hospital Universitaire Erasme Brussel

    Brussels, 1070

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Hungary2 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Javorszky Odon Hospital

    Vác, 2600

Other trials in Hungary

Canada1 site

  • Sudbury Endoscopy Centre

    Greater Sudbury, Ontario, P3C 5K6

Other trials in Canada

Switzerland1 site

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

United Kingdom1 site

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

Other trials in United Kingdom

About this study

Official title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

Conditions
Crohn's Disease
Being tested
Mirikizumab, Placebo
Keywords
inflammatory bowel disease, IL-23, biologic
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

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

  • MirikizumabDrug

    Also called LY3074828

  • PlaceboDrug

Study groups in NCT02891226
Study groupRoleWhat they receive
MirikizumabExperimentalPeriod 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W). Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1. Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.
Receives: Drug: Mirikizumab
PlaceboPlacebo comparatorPeriod 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants Achieving Endoscopic Response at Week 12

    Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; >2 cm = score 3); extent of ulcerated surface (none = 0; <10% = 1;10-30% = 2;>30% = 3);extent of affected surface (none = 0; <50% = 1;50-75% = 2;>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Achieving Endoscopic Remission at Week 12

    Endoscopic remission defined as SES-CD of <4 ileal-colonic or <2 for isolated ileal disease, and no subscore >1 at week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: (ileum; right, transverse, and left colon; and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; greater than (>) 2 cm = score 3); extent of ulcerated surface (none = 0; less than (<) 10% = 1; 10-30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50-75% = 2; >75% = 3); and presence and type of narrowings (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.

    Measured: Week 12

  2. Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

    PRO remission is defined as stool frequency (SF) ≤2.5 and abdominal pain (AP) ≤1 and no worse than baseline at week 12. SF captures the number of liquid or very soft stools. AP score is classified as 0=none, 1=mild, 2=moderate, 3=severe.

    Measured: Week 12

  3. Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12

    The PGRS is a 1-item patient-rated questionnaire designed to assess the participant's rating of their disease symptom severity over the past 24 hours. Responses are graded on a 6-point scale in which a score of 1 indicates the subject has no symptoms (that is, "none") and a score of 6 indicates that the participant's symptom are "very severe." Least Squares Mean (LS Mean) was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

    Measured: Baseline, Week 12

  4. Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12

    The PGRC scale is a patient-rated instrument designed to assess the participant's rating of change in their symptom(s). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the participant's symptom is "very much better," a score of 4 indicates that the participant's symptom has experienced "no change," and a score of 7 indicates that the participant's symptom is "very much worse."

    Measured: Baseline, Week 12

  5. Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

    The IBDQ is a 32-item self-administered questionnaire. The IBDQ has 4 dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

    Measured: Baseline, Week 12

  6. Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0-4 associated with a range over "Not at all" to "Very much" for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

    Measured: Baseline, Week 12

  7. Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains:physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

    Measured: Baseline, Week 12

  8. Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

    Population mean (between-subject coefficient variance [CV %]) apparent clearance. Clearance is estimated based on concentration data collected in the time frame of 0-208 weeks.

    Measured: Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion

  9. Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

    Population mean (between-subject coefficient variance [CV %]) apparent volume of distribution. Volume of distribution is estimated based on concentration data collected in the time frame of 0-208 weeks.

    Measured: Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion

Timeline

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

  1. First posted7 Sep 2016 (estimated)
  2. Study start14 Dec 2016
  3. Primary completion11 Dec 2018
  4. Study completion5 Feb 2021

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891226
Sponsor's protocol ID
16492
Other IDs
I6T-MC-AMAG, 2016-002204-84, 2016
Acronym
SERENITY
Status last verified
Aug 2022
First submitted
1 Sep 2016
Last updated
30 Aug 2022
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Jairath V, Hunter Gibble T, Peyrin-Biroulet L, Sands BE, Hirai F, Hibi T, Loftus EV Jr, Cross RK, Protic M, Chan LS, Morris N, Traxler K, Rubin DT. Impact of mirikizumab on patient-reported outcomes and quality of life in patients with Crohn's disease: results from the phase 2 SERENITY study. Crohns Colitis 360. 2026 Mar 11;8(1):otag018. doi: 10.1093/crocol/otag018. eCollection 2026 Jan.

    PubMed 41908680

  • Chua L, Otani Y, Lin Z, Friedrich S, Durand F, Zhang XC. Mirikizumab Pharmacokinetics and Exposure-Response in Patients With Moderately-To-Severely Active Crohn's Disease: Results From Two Randomized Studies. Clin Transl Sci. 2025 Aug;18(8):e70320. doi: 10.1111/cts.70320.

    PubMed 40804779

  • Magro F, Protic M, De Hertogh G, Chan LS, Pollack P, Jairath V, Carlier H, Hon E, Feagan BG, Harpaz N, Pai R, Reinisch W. Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1878-1888.e10. doi: 10.1016/j.cgh.2023.11.010. Epub 2023 Nov 20.

    PubMed 37993033

  • Sands BE, Peyrin-Biroulet L, Kierkus J, Higgins PDR, Fischer M, Jairath V, Hirai F, D'Haens G, Belin RM, Miller D, Gomez-Valderas E, Naegeli AN, Tuttle JL, Pollack PF, Sandborn WJ. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology. 2022 Feb;162(2):495-508. doi: 10.1053/j.gastro.2021.10.050. Epub 2021 Nov 5.

    PubMed 34748774

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirikizumab in people with Crohn's Disease, run by Eli Lilly and Company at 108 sites in 14 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 2 inclusion and 4 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Japan, Russia, Ukraine, Poland and 9 more countries. 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 28 Feb 2022). 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?

Percentage of Participants Achieving Endoscopic Response at Week 12 (time frame: Week 12). 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 NCT02891226, which also lists 4 linked publications.

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 30 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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