A Phase 3, Multicentre, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease
- Conditions
- Bowel InflammationCrohn's Disease10017969
- Registration Number
- NL-OMON54068
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Some of the important criteria for study participants to be eligible for
inclusion in the study are (please refer section 5.1 of the protocol for more
details):
1. They have given written informed consent
2. They have participated in the Phase 2 Study AMAG and have:
a. completed the last visit of participation in the AMAG study and remained on
mirikizumab treatment in either the maintenance dosing period 3 or in the AMAG
extension period, and
b. in the opinion of the investigator, would derive clinical benefit from
continued treatment with mirikizumab.
It is preferred that participants receive the first dose of AMAX study drug
within approximately 6-8 weeks of the last dosing visit in AMAG. A maximum of
18 weeks will be allowed between the last dose in AMAG and the first dose in
AMAX to accommodate situations where due to circumstances outside the patient's
control, a patient may not be able to complete all required assessments within
the recommended shorter window.
3. They have participated in the Phase 3 Study AMAM and have:
a. completed Week 52 of the AMAM study, including the Week 52 endoscopy for
evaluation of Responder/Non-responder status, and in the opinion of the
investigator would derive clinical benefit from treatment with mirikizumab.
It is preferred that participants receive the first dose of AMAX study drug
within approximately 6-8 weeks after the last dosing visit in AMAM. A maximum
of 18 weeks will be allowed between the last dose in AMAM and the first dose in
AMAX to accommodate situations where due to circumstances outside the patient's
control, a patient may not be able to complete all required assessments within
the recommended shorter window.
4. They are willing and able to complete the scheduled study assessments,
including endoscopy, self-administer investigational product (or have caregiver
administer investigational product), and complete patient electronic and paper
diary.
5. They have clinically acceptable central laboratory test results at study
entry which would not have resulted in permanent discontinuation of treatment
in the originator study.
6. Contraception
a. Male Participants: No male contraception is required
b. Female Participants:
i. Women of childbearing potential: must test negative for pregnancy prior to
initiation of treatment as indicated by a negative urine pregnancy test at
Visit 1/Week 0 of this study
AND
ii. must agree to either remain abstinent, if complete abstinence is their
preferred and usual lifestyle, or remain in same-sex relationships, if part of
their preferred and usual lifestyle, without sexual relationships with males.
Periodic abstinence (for example, calendar, ovulation, symptothermal, or
post-ovulation methods), declaration of abstinence just for the duration of a
trial, and withdrawal are not acceptable methods of contraception,
OR
iii. must use a combination of 2 effective methods of contraception or 1 highly
effective method of contraception for the entirety of the study. Abstinence or
contraception must continue following completion of study drug administration
for 16 weeks.
iv. Women not of childbearing potential may participate and include those who
are:
a) infertile due to surgical sterilization (total hysterectomy, bilateral
salpingo-oophorectomy, bilat
Some of the important criteria for study participants to be excluded from the
study are (please refer section 5.2 of the protocol for more details):
3. They had a reported serious adverse event (SAE) in originator study or
developed other condition prior to AMAX Week 0 that would disqualify them from
treatment with mirikizumab according to originator study criteria.
4. Had permanently discontinued study drug in the originator study or had a
temporary interruption of study drug in originator study such that, in the
opinion of the investigator or Sponsor, restarting of mirikizumab would pose an
unacceptable risk for the participant in Study AMAX.
5. Presence of significant uncontrolled neuropsychiatric disorder or judged at
risk of suicide in the opinion of the investigator
6. Have a known hypersensitivity to any component of this investigational
product or monoclonal antibodies or has experienced an acute systemic
hypersensitivity event with previous study drug administration that precludes
mirikizumab therapy.
7. Are pregnant, lactating, or planning to become pregnant while enrolled in
the study or within 16 weeks after receiving the last dose of study drug.
9. Intend to receive a Bacillus Calmette Guerin (BCG) vaccination or a live
attenuated vaccine during the study.
10. Have any history or current evidence of cancer of the gastrointestinal
tract.
11. Have any current sporadic adenoma without dysplasia that has not been
removed. Once completely removed, the patient is eligible for the study.
12. Have any evidence of colonic dysplasia.
13. Are currently enrolled in any other clinical study involving an
investigational product or any other type of medical research judged not to be
scientifically or medically compatible with this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Proportion of participants achieving clinical remission by CDAI (defined as<br /><br>CDAI score <150) at Week 52 of AMAX<br /><br>- Proportion of participants achieving endoscopic response (defined by >=50%<br /><br>reduction from baseline in SES-CD Total Score) at Week 52 of AMAX</p><br>
- Secondary Outcome Measures
Name Time Method