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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03627091




Registration number
NCT03627091
Ethics application status
Date submitted
24/07/2018
Date registered
13/08/2018

Titles & IDs
Public title
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Scientific 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)
Secondary ID [1] 0 0
2017-000617-23
Secondary ID [2] 0 0
SHP647-307
Universal Trial Number (UTN)
Trial acronym
CARMEN CD 307
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ontamalimab
Other interventions - Placebo

Experimental: Ontamalimab 25 mg - Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).

Experimental: Ontamalimab 75 mg - Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).

Placebo comparator: Placebo - Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).


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

Other interventions: Placebo
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Remission at Week 52
Timepoint [1] 0 0
At Week 52
Primary outcome [2] 0 0
Number of Participants With Enhanced Endoscopic Response at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52
Timepoint [1] 0 0
At Week 52
Secondary outcome [2] 0 0
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [3] 0 0
Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52
Timepoint [3] 0 0
At Week 52
Secondary outcome [4] 0 0
Number of Participants With Sustained Clinical Remission at Week 52
Timepoint [4] 0 0
At Week 52
Secondary outcome [5] 0 0
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
Timepoint [5] 0 0
At Week 52
Secondary outcome [6] 0 0
Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52
Timepoint [6] 0 0
At Week 52
Secondary outcome [7] 0 0
Number of Participants With Complete Endoscopic Healing at Week 52
Timepoint [7] 0 0
At Week 52

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2021
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
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Portugal
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Lisboa
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Portugal
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Bucuresti
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Serbia
State/province [156] 0 0
Šumadijski Okrug
Country [157] 0 0
Slovakia
State/province [157] 0 0
Nitra
Country [158] 0 0
Slovakia
State/province [158] 0 0
Presov
Country [159] 0 0
South Africa
State/province [159] 0 0
Gauteng
Country [160] 0 0
South Africa
State/province [160] 0 0
Western Cape
Country [161] 0 0
Spain
State/province [161] 0 0
Córdoba
Country [162] 0 0
Spain
State/province [162] 0 0
Madrid, Communidad Delaware
Country [163] 0 0
Spain
State/province [163] 0 0
Madrid
Country [164] 0 0
Spain
State/province [164] 0 0
Pontevedra
Country [165] 0 0
Spain
State/province [165] 0 0
Barcelona
Country [166] 0 0
Spain
State/province [166] 0 0
Huelva
Country [167] 0 0
Spain
State/province [167] 0 0
Sevilla
Country [168] 0 0
Turkey
State/province [168] 0 0
Mersin
Country [169] 0 0
Ukraine
State/province [169] 0 0
Chernivets'ka Oblast
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kharkivs'ka Oblast
Country [171] 0 0
Ukraine
State/province [171] 0 0
Kyïv
Country [172] 0 0
Ukraine
State/province [172] 0 0
Dnipro
Country [173] 0 0
Ukraine
State/province [173] 0 0
Kharkiv
Country [174] 0 0
Ukraine
State/province [174] 0 0
Kherson
Country [175] 0 0
Ukraine
State/province [175] 0 0
Kyiv
Country [176] 0 0
Ukraine
State/province [176] 0 0
Lviv
Country [177] 0 0
Ukraine
State/province [177] 0 0
Vinnytsia
Country [178] 0 0
Ukraine
State/province [178] 0 0
Zaporizhzhia
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Northumberland
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Aberdeen
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Newport
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Shire
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03627091