Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Crohn's Disease Clinical Trial

— CARMEN CD 307  

Official title:

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03627091
• Other study ID #: SHP647-307
• Secondary ID: 2017-000617-23
• Status: Terminated
• Phase: Phase 3
• Start date: February 6, 2019
• Est. completion date: September 13, 2021

Study information

• Verified date: March 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 13, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.

• Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.

• Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:

1. Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or

2. Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:

• Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.

• A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.

• A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

• A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.

*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.

• Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

• Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

• Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

• Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).

• Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.

• Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.

• Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.

• Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

• Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).

• Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.

• Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

• Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.

• Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.

1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).

2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).

6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)

7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

• Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.

• Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.

• Participants who are participating in other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Ontamalimab
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

Other:
• Placebo
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Locations

Country	Name	City	State
Argentina	Fundación Favaloro	Buenos Aires
Argentina	Hospital Privado Centro Médico de Córdoba	Córdoba
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincents Hospital Melbourne - PPDS	Fitzroy	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Mater Hospital Brisbane	South Brisbane	Queensland
Austria	LKH-Universitätsklinikum Klinikum Graz	Graz	Steiermark
Austria	Salzburger Landeskliniken	Salzburg
Austria	Klinikum Wels-Grieskirchen GmbH	Vienna	Wien
Austria	Medizinische Universitat Wien (Medical University of Vienna)	Wien
Belgium	Academisch Medisch Centrum Amsterdam	Bonheiden	Antwerpen
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge	Kortrijk	West-Vlaanderen
Belgium	CHU Mouscron	Mouscron
Bosnia and Herzegovina	Clinical Center Banja Luka	Banja Luka
Bulgaria	Multiprofile Hospital for Active Treatment Eurohospital	Plovdiv
Bulgaria	Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD	Sofia	Sofia-Grad
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia
Bulgaria	Medical Center Convex EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD - PPDS	Sofia
Bulgaria	Second Multiprofile Hospital for Active Treatment Sofia	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD	Sofia
Bulgaria	Diagnostic Consultative Centre Mladost - M OOD	Varna
Colombia	Fundación Valle Del Lili	Cali	Valle Del Cauca
Colombia	IPS Centro Médico Julián Coronel S.A.S. - PPDS	Cali
Croatia	Opca bolnica Bjelovar	Bjelovar
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Virovitica	Virovitica
Croatia	University Hospital Center Zagreb	Zagreb	Grad Zagreb
Estonia	OÜ LV Venter	Parnu
Estonia	West Tallinn Central Hospital	Tallinn
Germany	Universitätsklinikum der RWTH Aachen	Aachen	Nordrhein-Westfalen
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Gastroenterologische Facharztpraxis am Mexikoplatz	Berlin-Zehlendorf
Germany	Sana Klinikum Biberach	Biberach an der Riss
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Universitatsklinikum Jena	Jena	Thüringen
Germany	Universitatsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Uniklinik Köln	Köln	Nordrhein-Westfalen
Germany	Klinikum rechts der Isa der Technischen Universitaet Muenchen	Munich	Bayern
Germany	Gastro Campus Research GbR	Münster	Nordrhein-Westfalen
Greece	Ippokrateio General Hospital of Athens	Athens	Attiki
Greece	University General Hospital of Heraklion	Heraklion
Greece	Iatriko Palaiou Falirou	Paliao Faliro
Greece	University General Hospital of Patras	Patras
Greece	Euromedica - PPDS	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz	Bekescsaba
Hungary	ENDOMEDIX Kft.	Budapest
Hungary	Magyar Honvédség Egészségügyi Központ	Budapest
Hungary	Pannónia Magánorvosi Centrum Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Mohacsi Korhaz	Mohacs
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Hungary	Tolna Megyei Balassa János Kórház	Szekszard
Ireland	St Vincent's University Hospital	Dublin
Israel	Hadassah Medical Center - PPDS	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Baruch Padeh Poriya Medical Center	Tiberias
Italy	Azienda Ospedaliera Mater Domini Di Catanzaro	Catanzaro	Calabria
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena	Emilia-Romagna
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	Veneto
Italy	A.O.U. Maggiore della Carità	Novara
Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	Pavia
Italy	Fondazione Policlinico Universitario A Gemelli	Roma	Lazio
Italy	La Sapienza-Università di Roma-Policlinico Umberto I	Roma
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Italy	Ospedale Casa Sollievo Della Sofferenza IRCCS	San Giovanni Rotondo
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino
Japan	Kunimoto Hospital	Asahikawa
Japan	Medical Corporation Aoyama Clinic	Kobe-shi	Hyôgo
Japan	Hidaka Coloproctology Clinic	Kurume-shi
Japan	Jikei University Hospital	Minato-ku	Tokyo
Japan	Aichi Medical University Hospital	Nagakute
Japan	Nishinomiya Municipal Central Hospital	Nishinomiya
Japan	Hyogo College of Medicine	Nishinomiya-shi	Hyôgo
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-city	Ôita
Japan	Ome Municipal General Hospital	Ome	Tokyo
Japan	Onomichi General Hospital	Onomichi
Japan	Chiinkai Dojima General & Gastroenterology Clinic	Osaka
Japan	Yodogawa Christian Hospital	Osaka
Japan	Kinshukai Infusion Clinic	Osaka-shi
Japan	Shiga University of Medical Science Hospital	Otsu-Shi
Japan	Toho University Sakura Medical Center	Sakura
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaidô
Japan	Sapporo Tokushukai Hospital	Sapporo-shi
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun
Japan	Nihonbashi Egawa Clinic	Tokyo
Japan	Colo-Proctology Center Matsushima Clinic	Yokohama
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam	Gyeonggido
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggido
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gang'weondo
Lebanon	Al Zahraa University Hospital	Beirut
Lebanon	Hammoud Hospital University Medical Center	Saida
Lithuania	Vilnius City Clinical Hospital	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Mexico	Clinica de Higado y Gastroenterologia Integral, S.C.	Cuernavaca	Morelos
Mexico	JM Research S.C	Cuernavaca	Morelos
Mexico	Centro de Investigacion Clinica Acelerada, S.C.	Distrito Federal
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Unidad de Atencion Medica e Investigacion en Salud	Merida	Yucatán
Mexico	Accelerium, S. de R.L. de C.V.	Monterrey	Nuevo León
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Netherlands	NWZ, location Alkmaar	Den Helder	Noord-Holland
Netherlands	ETZ-Elisabeth	Tilburg	Noord-Brabant
New Zealand	Dunedin Hospital	Dunedin	South Island
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Newtown	Wellington
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Vitamed Galaj i Cichomski sp.j.	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Czestochowa - PRATIA - PPDS	Czestochowa
Poland	Centrum Medyczne Gdynia - PRATIA - PPDS	Gdynia
Poland	NZOZ All Medicus	Katowice
Poland	Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii	Konskie	Swietokrzyskie
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Med Gastr Sp.z.o.o Sp.k	Lodz
Poland	Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.	Lódz	Lódzkie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny	Lódz	Lódzkie
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sól
Poland	Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa	Poznan
Poland	Centrum Medyczne Warszawa - PRATIA - PPDS	Rzeszow
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	Endoskopia Sp. z o.o.	Sopot	Pomorskie
Poland	Sonomed Sp. z o.o.	Szczecin
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj	Torun	Kujawsko-pomorskie
Poland	BioVirtus Centrum Medyczne	Warszawa
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Poland	Centrum Zdrowia M D M	Warszawa
Poland	Miedzyleski Szpital Specjalistyczny w Warszawie	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa	Mazowieckie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED	Warszawa	Mazowieckie
Poland	Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.	Wloclawek	Kujawsko-pomorskie
Poland	Lexmedica	Wroclaw	Dolnoslaskie
Poland	Melita Medical	Wroclaw	Dolnoslaskie
Poland	Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II	Zamosc
Portugal	Hospital Senhora da Oliveira - Guimaraes, E.P.E	Guimarães
Portugal	Hospital da Luz	Lisboa
Portugal	Centro Hospitalar do Algarve - Hospital de Portimao	Portimão
Romania	Colentina Clinical Hospital	Bucharest
Romania	Dr.Carol Davila Emergency University Central Military Hospital	Bucharest
Romania	Emergency University Hospital	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	Prof. Dr. Matei Bals Institute of Infectious Diseases	Bucharest
Romania	Sana Monitoring SRL	Bucharest	Bucuresti
Romania	Centrul Medical Hifu Terramed Conformal S.R.L.	Bucuresti
Romania	Cluj-Napoca Emergency Clinical County Hospital	Cluj-Napoca	Cluj
Romania	Affidea Romania SRL	Constanta
Romania	Gastromedica SRL	Iasi
Romania	Dr. Tirnaveanu Amelita Private Practice	Oradea
Romania	Dr. Goldis Gastroenterology Center SRL	Timisoara
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Russian Medical Military Academy n.a. S.M. Kirov	Saint Petersburg
Russian Federation	Medical University Reaviz	Samara
Russian Federation	Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city	Samara
Russian Federation	SHI Regional Clinical Hospital	Saratov
Russian Federation	St. Elizabeth Municipal Clinical Hospital	St. Petersburg
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac	Šumadijski Okrug
Serbia	University Clinical Center Nis	Nis
Serbia	General Hospital Vrsac	Vrsac
Serbia	Clinical Hospital Center Zemun	Zemun
Slovakia	KM Management, spol. s r.o.	Nitra
Slovakia	Gastro LM, s.r.o.	Presov
South Africa	Dr JP Wright	Claremont	Western Cape
South Africa	CLINRESCO, ARWYP Medical Suites	Johannesburg	Gauteng
South Africa	Dr. J Breedt	Pretoria	Gauteng
Spain	Centro Medico Teknon - Grupo Quironsalud	Barcelona
Spain	C.H. Regional Reina Sofia - PPDS	Cordoba	Córdoba
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital General Universitario Gregorio Maranon	Madrid	Madrid, Communidad Delaware
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	CHUVI - H.U. Alvaro Cunqueiro	Vigo	Pontevedra
Turkey	Mersin University Medical Faculty	Mersin
Ukraine	Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"	Chernivtsi	Chernivets'ka Oblast
Ukraine	LLC Medical Center Family Medicine Clinic	Dnipro
Ukraine	Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital	Kharkiv
Ukraine	Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council	Kharkiv	Kharkivs'ka Oblast
Ukraine	Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh	Kherson
Ukraine	Medical Center of LLC Medical Center Dopomoga-Plus	Kyiv
Ukraine	Medical Center of LLC Medical Clinic Blagomed	Kyiv
Ukraine	Medical Center OK!Clinic+LLC International Institute of Clinical Research	Kyiv
Ukraine	Municipal Institution of KRC Kyiv Regional Hospital #2	Kyiv
Ukraine	Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital	Kyiv	Kyïv
Ukraine	Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital	Lviv
Ukraine	Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1	Vinnytsia
Ukraine	MNPE City Hospital No. 6 of Zaporizhzhia City Council	Zaporizhzhia
United Kingdom	Aberdeen Royal Infirmary - PPDS	Aberdeen
United Kingdom	Royal Gwent Hospital - PPDS	Newport
United Kingdom	North Tyneside General Hospital	North Shields	Northumberland
United Kingdom	New Cross Hospital	Wolverhampton
United States	Advanced Research Center	Anaheim	California
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Gastroenterology Specialists, PC	Atlanta	Georgia
United States	Infinite Clinical Trials	Atlanta	Georgia
United States	HP Clinical Research	Bountiful	Utah
United States	Commonwealth Clinical Studies LLC	Brockton	Massachusetts
United States	New York Total Medical Care PC	Brooklyn	New York
United States	Renaissance Research Medical Group, INC	Cape Coral	Florida
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Loretto Hospital	Chicago	Illinois
United States	Consultants For Clinical Research Inc	Cincinnati	Ohio
United States	Consultants For Clinical Research Inc	Cincinnati	Ohio
United States	Gastro Florida	Clearwater	Florida
United States	Asthma and Allergy Associates PC - CRN - PPDS	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Advanced Clinical Research Network	Coral Gables	Florida
United States	Alliance Medical Research LLC	Coral Springs	Florida
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Northside Gastroenterology	Cypress	Texas
United States	Atlanta Center For Gastroenterology PC	Decatur	Georgia
United States	Mayo Clinic Health System - PPDS	Duluth	Minnesota
United States	Consultants For Clinical Research Inc	Fairfield	Ohio
United States	Mid Atlantic Health Specialists	Galax	Virginia
United States	Digestive Health Associates of Texas, P.A.dba DHAT Research Institute	Garland	Texas
United States	Gastro One	Germantown	Tennessee
United States	NYU Langone Long Island Clinical Research Associates	Great Neck	New York
United States	IL Gastroenterology Group	Gurnee	Illinois
United States	National Clinical, LLC	Hamtramck	Michigan
United States	Gastroenterology Associates of Hazard	Hazard	Kentucky
United States	CroNOLA, LLC.	Houma	Louisiana
United States	BI Research Center	Houston	Texas
United States	Biopharma Informatic Inc.	Houston	Texas
United States	Precision Research Institute, LLC	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	SIH Research	Kissimmee	Florida
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	OM Research LLC - Lancaster - ClinEdge - PPDS	Lancaster	California
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Atria Clinical Research - Clinedge - PPDS	Little Rock	Arkansas
United States	Arizona Digestive Health Mesa - East	Mesa	Arizona
United States	Hi Tech and Global Research, LLc	Miami	Florida
United States	Sanchez Clinical Research, Inc	Miami	Florida
United States	Crystal Biomedical Research	Miami Lakes	Florida
United States	Laporte County Institute For Clinical Research	Michigan City	Indiana
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Pharma Research International Inc	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	DelRicht Clinical Research, LLC - ClinEdge - PPDS	New Orleans	Louisiana
United States	Encompass Care	North Las Vegas	Nevada
United States	Southtowns Gastroenterology, PLLC	Orchard Park	New York
United States	Omega Research Consultants LLC - Clinedge - PPDS	Orlando	Florida
United States	Elite Clinical Studies - Phoenix - Clinedge - PPDS	Phoenix	Arizona
United States	Accel Research Sites - St. Petersburg - ERN - PPDS	Pinellas Park	Florida
United States	Alliance Clinical Research-(Vestavia Hills)	Poway	California
United States	Inland Empire Liver Foundation	Rialto	California
United States	East Coast Institute for Research, LLC	Saint Augustine	Florida
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Minnesota Gastroenterology PA	Saint Paul	Minnesota
United States	Southern Star Research Institute LLC	San Antonio	Texas
United States	Care Access Research, San Pablo	San Pablo	California
United States	Louisiana Research Center LLC	Shreveport	Louisiana
United States	Penn State Hershey Medical Group	State College	Pennsylvania
United States	Piedmont Healthcare	Statesville	North Carolina
United States	DBC Research	Tamarac	Florida
United States	Bayside Clinical Research - New Port Richey	Tampa	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	CATS Research Center - University of Arizona	Tucson	Arizona
United States	Advanced Gastroenterology-Union City	Union City	Tennessee
United States	Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS	Webster	Texas
United States	Winchester Gastroenterology Associates	Winchester	Massachusetts
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Gastroenterology Associates of Western Michigan, PLC	Wyoming	Michigan
United States	Digestive Disease Associates	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Colombia,  Croatia,  Estonia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Remission at Week 52	Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported.	At Week 52
Primary	Number of Participants With Enhanced Endoscopic Response at Week 52	Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823] baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported.	At Week 52
Secondary	Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52	Clinical remission was defined as a CDAI score of <150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported.	At Week 52
Secondary	Number of Participants With Glucocorticoid-free Clinical Remission at Week 52	Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders. Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported.	At Week 52
Secondary	Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52	Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain <=1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over the 7 most recent days and average daily stool frequency <=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported.	At Week 52
Secondary	Number of Participants With Sustained Clinical Remission at Week 52	Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Number of participants with sustained clinical remission at Week 52 were reported.	At Week 52
Secondary	Number of Participants With Sustained Enhanced Endoscopic Response at Week 52	Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Number of participants with sustained enhanced endoscopic response at Week 52 were reported.	At Week 52
Secondary	Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52	Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency <= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders.	At Week 52
Secondary	Number of Participants With Complete Endoscopic Healing at Week 52	Complete endoscopic healing was defined as SES-CD scale score from 0-2. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported.	At Week 52

External Links

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