Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
6 December 2021 |
Main ID: |
NCT03627091 |
Date of registration:
|
24/07/2018 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
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) |
Date of first enrolment:
|
February 6, 2019 |
Target sample size:
|
40 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT03627091 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
Phase:
|
Phase 3
|
|
Countries of recruitment
|
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
|
United States
| | | | | | |
Contacts
|
Name:
|
Study Director |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Shire |
| | |
Key inclusion & exclusion criteria
|
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
Age minimum:
16 Years
Age maximum:
80 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Crohn's Disease
|
Intervention(s)
|
Drug: Ontamalimab
|
Other: Placebo
|
Primary Outcome(s)
|
Number of Participants With Enhanced Endoscopic Response at Week 52
[Time Frame: Week 52]
|
Number of Participants With Clinical Remission at Week 52
[Time Frame: Week 52]
|
Secondary Outcome(s)
|
Number of Participants With Clinical Remission as Defined by Crohn's Disease (CD) e-diary Subscores at Week 52
[Time Frame: Week 52]
|
Number of Participants With Complete Endoscopic Healing at Week 52
[Time Frame: Week 52]
|
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
[Time Frame: Week 52]
|
Number of Participants With Clinical Remission and Enhanced Endoscopic Response at Week 52
[Time Frame: Week 52]
|
Number of Participants With Sustained Clinical Remission at Week 52
[Time Frame: Baseline up to Week 52]
|
Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) Less Than (<) 150 at Week 52
[Time Frame: Week 52]
|
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
[Time Frame: Baseline up to Week 52]
|
Secondary ID(s)
|
SHP647-307
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|