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Colitis, UlcerativePhase 2INSTRUCT-UCNCT04677179

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase 2 study testing LY3471851 in people with Colitis, Ulcerative, run by Nektar Therapeutics at 116 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
LY3471851
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
116 sitesin 22 countries
Study dates
22 Mar 2021to 9 Aug 2022
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

  • Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) ≥2, with endoscopy performed within 14 days before baseline.
  • Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of involved colon).
  • Have up-to-date colorectal cancer surveillance performed according to local standard.
  • Participants are either one of the following:
  • Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
  • Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
  • Have had an established diagnosis of UC of ≥3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
  • Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.

Who cannot join

  • Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
  • Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening.
  • Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
  • Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor).
  • Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
  • Have any history or evidence of cancer of the gastrointestinal tract
  • Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.

Trial locations and contacts

116 sites in 22 countries.

116 sites in 22 countries

Japan13 sites

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka

  • Sai Gastroenterologist Proctology

    Fujiidera, Osaka, 583-0027

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Matsuda Hospital

    Hamamatsu, Shizuoka, 4328061

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Showa University Koto Toyosu Hospital

    Koto-ku, Tokyo, 135 8577

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Infusion Clinic

    Osaka, Osaka, 530-0011

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004 0041

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo-To, 162 8655

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

  • Yamagata University Hospital

    Yamagata, 990-9585

Other trials in Japan

Ukraine10 sites

  • Medical Center of LLC Medical Center Clinic of Family Medicine

    Dnipro

  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

    Kiev, Kyiv Oblast, 4050

  • International Institute of Clinical Trials LLC

    Kyiv, 02091

  • Lviv Railway Clinical Hospital

    Lviv, Lviv Oblast, 79000

  • Lviv Regional Endocrinology Dispensary

    Lviv, Lviv Oblast, 79000

  • Communal Enterprise "Odesa Regional Clinical Hospital"

    Odesa, 65000

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88018

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, 21029

  • Vinnytsia War Veterans Regional Clinical Hospital

    Vinnytsia

  • Diacenter LLC

    Zaporizhzhya, 69076

Other trials in Ukraine

China9 sites

  • First affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Anhui Medical University

    HefeiCity, Anhui, 230022

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • Taian City Central Hospital

    Taian, Shandong, 271000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

    Wuhan, Hubei, 430030

Other trials in China

Brazil8 sites

  • Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

    Botucatu, São Paulo, 18618-687

  • Chronos Pesquisa Clínica

    Brasília, Federal District, 72145-450

  • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

    Campinas, São Paulo, 13060-904

  • Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Pesquisare

    Santo André, São Paulo, 09080-110

  • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

    São Bernardo do Campo, São Paulo, 09715-090

  • Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

    São Paulo, São Paulo, 04039-004

  • Hepatogastro

    São Paulo, 04543-001

Other trials in Brazil

India8 sites

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Apollo Speciality Hospital - Teynampet

    Chennai, Tamil Nadu, 600035

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302006

  • Kingsway Hospital

    Nagpur, Maharashtra, 440001

  • Midas Multispeciality Hospital Pvt.Ltd.

    Nagpur, Maharashtra, 440010

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360004

  • Gujarat Hospital - Gastro and Vascular Centre

    Surat, Gujarat, 395009

  • Gandhi Hospital

    Telangana, 500003

Other trials in India

United States7 sites

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • I.H.S. Health, LLC

    Kissimmee, Florida, 34741

  • Dedicated Clinical Research

    Litchfield Park, Arizona, 85340

  • Atlantic Digestive Health Institute

    Morristown, New Jersey, 07960

  • Care Access Research - Ogden

    Ogden, Utah, 84403

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

Other trials in United States

Russia7 sites

  • Olla-Med

    Moscow, Moscow, 105554

  • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice

    Moscow

  • Novosibirski Gastrocenter

    Novosibirsk, Novosibirsk Oblast, 630007

  • The University Clinic of OSMU

    Omsk, 644050

  • Rostov State Medical University

    Rostov-on-Don, Rostov Oblast, 344091

  • SPb SBIH "City Mariinskaya Hospital"

    Saint Petersburg, 194104

  • GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

    Saint Petersburg, 195067

Other trials in Russia

Romania6 sites

  • SC Med Life SA

    Bucharest, 010719

  • SC Centrul Medical Sana SRL

    Bucharest, 011025

  • Spital Clinic Colentina

    Bucharest

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400006

  • SC Pelican SRL

    Oradea, Bihor County, 410469

  • S.C. Materna Care S.R.L.

    Timișoara, 300645

Other trials in Romania

Czechia5 sites

  • MUDr. Gregar, s.r.o.

    Olomouc, 779 00

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • A-Shine

    Pilsen, Plzeň-město, 312 00

  • I. Interni klinika FN Plzen

    Plzen-Lochotin, 304 60

  • Nemocnice Slaný

    Slaný, 274 01

Other trials in Czechia

South Korea5 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, Gangwon-do, 26426

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443380

Other trials in South Korea

United Kingdom5 sites

  • Royal Derby Hospital

    Derby, Derbyshire, DE22 3NE

  • Whipps Cross University Hospital

    Leytonstone, London, E11 1NR

  • Guys/St. Thomas Hospital

    London, Surrey, SE1 9RT

  • St. George's Hospital

    London, SW17 0QT

  • York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Argentina4 sites

  • DOM- Centro de Reumatologia

    CABA, Buenos Aires, 1111

  • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

    CABA, Buenos Aires, C1431FWO

  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

    Ciudad Autonoma de Buenos Air, Buenos Aires, C1128AAF

  • Centro Médico Privado de Reumatología

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Australia4 sites

  • Paratus Clinical Research Brisbane

    Albion, Queensland, 4010

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Mater Adult Hospital Brisbane

    South Brisbane, Queensland, 4700

Other trials in Australia

Canada4 sites

  • Gastroenterology and internal medicine research institute

    Edmonton, Alberta, T5R 1W2

  • CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne

    Greenfield Park, Quebec, J4V2H1

  • Gastroenterology Research, Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H2Y9

  • McGill University

    Montreal, Quebec, H3G 1A4

Other trials in Canada

Hungary4 sites

  • Clinexpert SMO

    Budapest, 1033

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • Bugát Pál Kórház

    Gyöngyös, 3200

  • CLINFAN Szolgáltató Kft

    Szekszárd, 7100

Other trials in Hungary

Poland4 sites

  • Szpital Miejski Sw. Jana Pawla II

    Elblag, 82-300

  • NZOZ Vivamed

    Warsaw, Masovian Voivodeship, 03-580

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • ETG Zamość

    Zamość, 22-400

Other trials in Poland

Belgium3 sites

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, Bruxelles-Capitale, Région de, 1070

  • AZ Maria Middelares

    Ghent, 9100

  • Centre Hospitalier de Wallonie Picarde - Site Notre Dame

    Tournai, Wallonne, Région, 7500

Other trials in Belgium

Israel3 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Galilee Medical Center - Internal A

    Nahariya, 22100

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

France2 sites

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, 38043

  • Centre Hospitalier de Mont de Marsan

    Mont-de-Marsan, 40024

Other trials in France

Georgia2 sites

  • Acad. F. Todua Medical Center - Research Institute of Clinical Medicine

    Tbilisi, 0112

  • Medical Center: Medinvestment

    Tbilisi, 0186

Other trials in Georgia

Slovakia2 sites

  • FNsP FDRoosevelta Banska Bystrica

    Banská Bystrica, 97517

  • ENDOMED s.r.o.

    Košice, 04013

Other trials in Slovakia

Latvia1 site

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, Riga, LV-1002

Other trials in Latvia

About this study

Official title: An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

Read the detailed description

In stage 1, two doses (high and low) of LY3471851 will be compared to placebo. In stage 2, up to two additional doses (to be confirmed) of LY3471851 will be compared to placebo.

LY3471851 (NKTR-358) is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Being tested
LY3471851, Placebo
Keywords
T regulatory cells (Tregs), Interleukin 2, Interleukin-2
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • LY3471851Drug

    Also called NKTR-358

    administered SC

  • PlaceboDrug

    administered SC

Study groups in NCT04677179
Study groupRoleWhat they receive
High dose LY3471851ExperimentalParticipants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Receives: Drug: LY3471851
Low dose LY3471851ExperimentalParticipants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Receives: Drug: LY3471851
PlaceboPlacebo comparatorParticipants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Receives: Drug: LY3471851; Drug: Placebo

What is being measured

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

  1. Percentage of Participants Who Achieved Clinical Remission at Week 12

    Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Who Achieved Clinical Response at Week 12

    Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

  2. Percentage of Participants Who Achieved Endoscopic Remission at Week 12

    Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

  3. Percentage of Participants Who Achieved Endoscopic Response at Week 12

    Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

  4. Percentage of Participants Who Achieved Symptomatic Remission at Week 12

    Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

  5. Percentage of Participants Who Achieved Symptomatic Response at Week 12

    Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

    Measured: Week 12

  6. Percentage of Participants Who Achieved Histologic Remission at Week 12

    Histologic Remission is defined as Geboes score <2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.

    Measured: Week 12

  7. Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)

    HEMH is defined as Geboes score <2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).

    Measured: Week 12

  8. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score

    IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4 to 6] or [7 to 9]) and region (North America/Europe/Other) as fixed factors.

    Measured: Baseline, Week 12

  9. Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12

    C-trough is the concentration of drug in the blood immediately before the next dose was administered.

    Measured: Predose at week 12

Timeline

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

  1. First posted21 Dec 2020
  2. Study start22 Mar 2021
  3. Primary completion9 Aug 2022
  4. Study completion9 Aug 2022

Why it stopped: Study terminated due to enrollment futility.

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
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04677179
Sponsor's protocol ID
17287
Other IDs
J1P-MC-KFAH, 2020-003017-35
Acronym
INSTRUCT-UC
Status last verified
Aug 2023
First submitted
8 Dec 2020
Last updated
5 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3471851 in people with Colitis, Ulcerative, run by Nektar Therapeutics at 116 sites in 22 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 8 inclusion and 7 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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Japan, Ukraine, China, Brazil, India and 17 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 5 Sep 2023). 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 Who Achieved Clinical Remission 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 NCT04677179.

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 5 Sep 2023.

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