A Phase 2 Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF 057 in Adults with Moderately to Severely Active Crohns Disease GARNET.
Canada Austria Brazil Colombia Croatia Czech Republic France Georgia Germany Hungary India Italy Kazakhstan Latvia Mexico Poland Romania Serbia Slovakia Spain United States of America
North Kaloor, Kaloor, Ernakulam, Kerala, 682018, India Ernakulam KERALA
9846045469
drmathewphilip@gmail.com
Dr Kaushal Madan
Max Smart Super Speciality Hospita
Saket (A Unit of Gujarmal Modi Hospital and Research Centre for Medical Sciences), Gate No 6 , Press Enclave Road, Mandir Marg, Saket, Delhi, 110017, India South DELHI
9958787720
kaushal.madan@maxhealthcare.com
Dr Kaivan Shah
Navneet Memorial Hospital
Opp. Sardar Patel Seva Samaj Hall, In Lane, Opp. Navrangpura Telephone Exchange, Off C.G Road, Ahmedabad, Gujarat, 380009, India Ahmadabad GUJARAT
9833622433
drkaivanshah12@gmail.com
Dr Pramod Katare
Noble Hospital Pvt Ltd
153, Magarpatta City Road, Hadapsar, Pune, Maharashtra, 411013, India Pune MAHARASHTRA
8830793201
drkatareps@gmail.com
Dr Krishnkant Rawal
Prime Institute of Digestive Sciences
Prime Institute of Digestive Sciences - panchvati main road, Atithi chownk corner, nana mava road, Beside chandresh vadi, Rajkot, Gujarat, 360001, India Rajkot GUJARAT
9824212169
kkrawal@gmail.com
Dr Mukesh Kalla
S.R.Kalla Memorial Gastro and General Hospital
S.R.Kalla Memorial Gastro and General Hospital, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur, Rajasthan, 302006, India Jaipur RAJASTHAN
9829050622
drmkalla@rediffmail.com
Dr Hemant Kumar Gupta
Samvedna Hospital
Department of Gastroenterology - B27/88G Ravindrapuri, Varanasi, Uttar Pradesh, 221005, India Varanasi UTTAR PRADESH
9415336365
hemantkrg26@yahoo.com
Dr Chetan Mehta
Shree Giriraj Multispeciality Hospital
Department of Gastroenterology - 27-Navjyot Park Corner, 150 Feet Ring Road, Rajkot, Gujarat, 360005, India Rajkot GUJARAT
9825077472
mehtacn@hotmail.com
Dr Mayank Kabrawala
SIDS Hospital and Research Centre
Department of Gastroenterology - A unit of SIDS health care private limited, Off ring road, Near shell petrol pump, Ring road-sosyo circle lane, Surat, Gujarat, 395002, India Surat GUJARAT
9825130363
mayankkabrawala@hotmail.com
Dr Gaurav Kumar Gupta
SMS Medical College & Attached Hospitals
Vivekananda Marg, C-Scheme, Jaipur,Rajasthan, 302004, India Jaipur RAJASTHAN
09214027938
drgauravsms@gmail.com
Dr Ravi Shankar B
Yashoda Hospital
Behind Hari Hara Kala Bhavan, SP road, Secunderabad, Telangana, 500003, India Hyderabad TELANGANA
Induction: Blinded dose of active MORF-057 for 14 weeks.
Maintenance: Open-label dose of active MORF-057 for 38 weeks.
Maintenance Extension: Open-label dose of active MORF-057 for 52 weeks.
Intervention
MORF-057
Induction: Blinded dose of active MORF-057 for 14 weeks.
Maintenance: Open-label dose of active MORF-057 for 38 weeks.
Maintenance Extension: Open-label dose of active MORF-057 for 52 weeks.
Comparator Agent
Placebo
Induction: Blinded matching placebo dose for 14 weeks.
Maintenance: Open-label dose of active MORF-057 for 38 weeks.
Maintenance Extension: Open-label dose of active MORF-057 for 52 weeks.
1. Has signs or symptoms of CD for at least 90 days prior to screening
2. Has a CDAI score of 220 to 450, with an average daily stool subscore equal or greater than 4 points and or an average daily abdominal pain subscore of equal or greater 2 points
3. Has an SES CD score of equal or greater 6 or an SES CD score of equal or greater 4 if CD is isolated to the ileum
4. Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments Corticosteroids, Immunosuppressants eg, azathioprine, 6 mercaptopurine, methotrexate and or advanced therapies for CD eg, biologic agents, Janus kinase JAK inhibitors, applicable investigational products
ExclusionCriteria
Details
1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
2. Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
3. Has had extensive bowel resection greater than100 cm, and or more than 3 resections, and or has a known diagnosis of short bowel syndrome
4. Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
5. Has positive findings on a subjective neurological screening questionnaire
6. Has a concurrent, clinically significant, serious, unstable comorbidity
7. Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
8. Is currently participating in any other interventional study or has received any investigational therapy within 30 days
9. Previous exposure to MORF 057 and or a known hypersensitivity to drugs with a similar mechanism to MORF 057
10. Unable to attend study visits or comply with study procedures
11. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
Baseline to Week 14
Secondary Outcome
Outcome
TimePoints
Proportion of participants with clinical response at Week 14 determined using the Crohns Disease Activity Index CDAI.
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by more than or equal to 100 points or a CDAI score of less than 150 points.
Baseline to Week 14
Proportion of participants with clinical remission at Week 14 determined using the CDAI.
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of less than 150 points.
Baseline to Week 14
Target Sample Size
Total Sample Size="210" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This study is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 (as capsule, P.O.) versus matching placebo in adult study participants with moderately to severely active CD.
Approximately 385 participants will be randomized into the Part A and Part B treatment groups across 200 centers worldwide.
This Phase 2 study will consist of a Screening Period (up to 6 weeks, consisting of Stage 1 and Stage 2 testing), a Treatment Period (52 weeks, including a 14-week Induction Period and a 38-week Maintenance Period), and a Safety Follow-up (SFU) Period (4 weeks).
All participants who complete the 52-week Treatment Period will have the opportunity to continue treatment in a 52-week Long-Term Extension (LTE).
An independent Data and Safety Monitoring Board (DSMB) will review participant safety data and monitor scientific integrity throughout the study.