This study has been transitioned to CTIS with ID 2023-507657-15-00 check the CTIS register for the current data. Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter, long-term extension study evaluating the efficacy and safety…
ID
Source
Brief title
LUCENT 3
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
The proportion of patients in clinical remission at Week 52
Secondary outcome
Efficacy:
• The proportion of patients in clinical remission at Week 100 or Week 160
• The proportion of patients in endoscopic remission at Week 52, Week 100 or
Week 160
• The proportion of patients with endoscopic subscore = 0 (ES=0) at Week 52,
Week 100 or Week 160
• Stool frequency and rectal bleeding subscores over time
• The proportion of patients in corticosteroid-free remission at Week 52, Week
100 or Week 160
• Among patients entering the AMAP study not on corticosteroids, the time to
first use of corticosteroids for UC
• Dose of corticosteroid used at Week 52, Week 100 or Week 160
• The proportion of patients in clinical remission at Week 52, Week 100 or Week
160
• The proportion of patients in endoscopic remission at Week 52, Week 100 or
Week 160
• The proportion of patients with ES = 0 at Week 52, Week 100 or Week 160
• Stool frequency and rectal bleeding subscores over time
• Among the patients who enter the AMAP study on corticosteroids, the
proportion in corticosteroid-free remission at Week 52, Week 100 or Week 160
• The proportion of patients in histologic remission at Week 52, Week 100 or
Week 160, as defined in the histopathology charter
Health Outcomes:
• IBDQ scores over time
• The proportion of patients who are hospitalized due to UC over time
• The proportion of patients who undergo UC surgeries including colectomy over
time
Background summary
Mirikizumab (LY3074828) is a humanized immunoglobulin G4 (IgG4) monoclonal
antibody that binds to the p19 subunit of interleukin-23 (IL-23), a cytokine
that has been implicated in mucosal inflammation. Study I6T-MC-AMAP (AMAP) is a
Phase 3 open-label clinical study designed to evaluate the long-term efficacy
and safety of mirikizumab in patients with moderately to severely active
ulcerative colitis (UC). Patients who have completed their participation in the
Phase 2 Study I6T-MC-AMAC (AMAC) or the Phase 3 Study I6T-MC-AMBG (AMBG) are
eligible for enrollment into Study AMAP. Patients from future mirikizumab UC
studies may also be eligible for Study AMAP.
Study objective
This study has been transitioned to CTIS with ID 2023-507657-15-00 check the CTIS register for the current data.
Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter,
long-term extension study evaluating the efficacy and safety of mirikizumab in
patients with moderately to severely active UC who have participated in an
originator mirikizumab UC study, including, but not limited to, the Phase 2
Study AMAC and the Phase 3 Study AMBG.
The planned maximum duration of treatment for each patient is approximately 3
years, or until mirikizumab is commercially available in the country in which
the patient resides, whichever occurs first. Patients may remain in Study AMAP
as long as study drug treatment is tolerated with no safety concerns and, in
the opinion of the investigator, the patient is deriving benefit from study
drug.
All patients, whether they discontinue study drug early for any reason or
complete mirikizumab
treatment in Study AMAP, will enter a 12-week posttreatment follow-up period
after the last dose of mirikizumab.
Study design
Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter,
long-term extension study evaluating the efficacy and safety of mirikizumab in
patients with moderately to severely active UC who have participated in an
originator mirikizumab UC study, including, but not limited to, the Phase 2
Study AMAC and the Phase 3 Study AMBG.
The planned maximum duration of treatment for each patient is approximately 3
years, or until mirikizumab is commercially available in the country in which
the patient resides, whichever occurs first. Patients may remain in Study AMAP
as long as study drug treatment is tolerated with no safety concerns and, in
the opinion of the investigator, the patient is deriving benefit from study
drug.
All patients, whether they discontinue study drug early for any reason or
complete mirikizumab
treatment in Study AMAP, will enter a 12-week posttreatment follow-up period
after the last dose of mirikizumab.
Patients from Study AMAC and Study AMBG are eligible for enrollment into Study
AMAP.
Intervention
Mirikizumab will be administered subcutaneously every 4 weeks. Patients will
receive open-label mirikizumab in Study AMAP, regardless of whether they were
receiving blinded or unblinded (open-label) mirikizumab or blinded placebo when
their participation ended in the originating study. No rescue with mirikizumab
will be offered during Study AMAP.
Endoscopy will be performed at Week 52 (Year 1), Week 100 (Year 2), and Week
160 (Year 3) of Study AMAP (See Section 2). The last endoscopy performed in the
originator study may be used as baseline for Study AMAP. Patients from Study
AMAC who have not had endoscopy performed within 8 months of Week 0 of Study
AMAP are to have an endoscopy performed at Week 0. Patients with pancolitis of
>8 years* duration, left-sided colitis of >12 years* duration, or primary
sclerosing cholangitis require colorectal cancer surveillance colonoscopy for
UC-associated dysplasia and malignancy. Patients with a family history of
colorectal cancer, personal history of increased colorectal cancer risk, age
>50 years, or with other known risk factors also require colonoscopy for
colorectal cancer surveillance. If these patients do not have documentation of
a surveillance colonoscopy (performed according to local standards) within 18
months of Week 0, a colonoscopy is to be performed at Week 0 for eligibility.
Colonoscopy is the required endoscopic procedure for these patients at Weeks
52, 100, and 160. A negative colonoscopy report is required for continuing
eligibility.
Study burden and risks
The investigational product required by Protocol and the study procedures are
associated with certain risks and discomforts, as described in the patient
information leaflet. The combination of experimental medicine and study
procedures may be associated with additional risks or discomforts that at this
point are not fully known.
Clinical Study Exposure Safety information from 28 clinical studies in 4673
study participants who have taken the investigational product has been
reviewed. This included 851 healthy adult participants, 2170 adult participants
with psoriasis, 1442 adult participants with ulcerative colitis, 186 are adult
participants with Crohn*s disease, and 24 are children under 18 years of age
with ulcerative colitis or Crohn*s disease.
Some study participants have had the following side effects when taking the
investigational product. Common side effects (1 or more out of 100 patients)
when taking the investigational product were: Pain, redness, or other symptoms
at injection site, Upper respiratory infection, Headache, and Rash. Uncommon
side effects (1 or more patients out of 1000) when taking the investigational
product were: Strong reaction that occurs at the start or during infusion into
a vein, and increases in blood tests that indicate problems with liver. Three
study participants died after having serious side effects. The study doctor
considered these side effects to be related to the investigational product:
Heart attack, cancer of the colon that had spread to other parts of the body,
and cancer of the cells in the lymph system.
Eleven study participants had life-threatening, serious side effects considered
related to the investigational product. Infections of the kidney, lungs, and
lining of the heart; Heart attack; Decreased blood flow to the heart; Cancer of
the stomach lining; Blood clot in the brain; Severe allergic reaction,
Increases in blood tests that indicate problems with the liver; Serious
infection at a body location that was not identified when receiving blinded
study drug
The investigational product has been given to 24 study participants who were
children under 18 years of age with ulcerative colitis or Crohn*s disease. Side
effects reported in 2 or more participants who received the investigational
product in these ongoing studies include: Fever (n = 7), Headache (n = 6), Pain
at injection site (n = 5), Rash (n = 3), Vomiting (n = 3), Constipation (n =
2), and Tiredness (n = 2).
The subjects undergo an number of study procedures such as SC injections, blood
collections, TB skin test, ECG tests and colonoscopy/endoscopy. These
procedures may also be accompanied by certain risks. The procedures may also
have other unknown risks. These risks are described in the Informed consent
form.
Eastgate Road 11
Little Island, Co. Cork T45 KD39
IE
Eastgate Road 11
Little Island, Co. Cork T45 KD39
IE
Listed location countries
Age
Inclusion criteria
1. Patients from the Phase 2 Study AMAC who in the opinion of the investigator,
would derive benefit from treatment with mirikizumab
2. Patients from the Phase 3 Study AMBG who in the opinion of the investigator,
would derive benefit from treatment with mirikizumab.
3. If female, must meet the contraception requirements.
Exclusion criteria
1. Patients who would not, in the opinion of the investigator, derive clinical
benefit from open-label treatment with mirikizumab.
2. Had a reported SAE in originator study or developed other condition prior to
Week 0 visit that would disqualify them from treatment with mirikizumab
according to originator study criteria.
3. Are diagnosed with any medical condition including developing malignancy or
suspicion of active malignant disease during the originator study or prior to
Week 0, which would have precluded enrollment in a prior mirikizumab study or
would have required discontinuation., 4. Participants diagnosed with clinically
important infection including, but not limited to, hepatitis B, hepatitis C,
HIV/AIDS, and active tuberculosis (TB) during either originator study.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-507657-15-00 |
| EudraCT | EUCTR2017-004092-31-NL |
| ClinicalTrials.gov | NCT03519945 |
| CCMO | NL65842.018.18 |