| CTRI Number |
CTRI/2023/11/059563 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
VTX958 for the Treatment of Moderately to Severely Active Crohns Disease |
|
Scientific Title of Study
|
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants with Moderately to Severely Active Crohn’s Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/23/000028 |
DCGI |
| 2022-003365-38 |
EudraCT |
| VTX958-202, version 2.0, 29 Nov 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
Bangalore
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
Radhika.Bobba@psi-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
Radhika.Bobba@psi-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO pharma India Pvt Ltd |
| Address |
PSI CRO Pharma India Pvt Ltd, 414 Shree complex, 73, St Johns Road, Bangalore, India- 560042
KARNATAKA
560042
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
Radhika.Bobba@psi-cro.com |
|
|
Source of Monetary or Material Support
|
| Ventyx Biosciences, Inc.
662 Encinitas Blvd, Suite 250
Encinitas, California 92024
United States |
|
|
Primary Sponsor
|
| Name |
PSI CRO Pharma India Pvt Ltd |
| Address |
414 Shree complex, 73, St Johns Road, Bangalore, India- 560042 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Belgium
Brazil
Bulgaria
Canada
Czech Republic
France
Georgia
Germany
Hungary
India
Israel
Italy
Lithuania
Poland
Serbia
Slovakia
Spain
United States of America |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajit Sood |
Dayanand Medical College and Hospital |
Department of Gastroenterology, Tagore Nagar, Civil Lines,Ludhiana-141001, Punjab, India
Ludhiana
PUNJAB |
9815400718
ajitsood10@gmail.com |
| Dr Nitin Shankar Behl |
Fortis Hospital |
Chandigarh Road, near Radha Soami Satsang Beas,Mundian Khurd, Ludhiana-141015,Punjab, India
Ludhiana
PUNJAB |
8427000080
drnitinbehl@gmail.com |
| Dr Ajay Kumar Patwa |
King George Medical University |
2nd floor Department of
Medicine, King George Medical
University Chowk, Lucknow-226003, Uttar Pradesh,
India
Lucknow
UTTAR PRADESH |
9455519306
drajaymd12345@gmail.com |
| Dr Kabrawala Mayank Vasantlal |
Surat Institute of Digestive Sciences (SIDS) |
Vijay Nagar Gate No-3,Besides NirmanBhavan, Opposite Gandhi College,Surat-395002, Gujarat, India
Surat
GUJARAT |
02612800000
mayankkabrawala@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee Dayanand Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Fortis Hospital |
Submittted/Under Review |
| Institutional Ethics Committee King Georges Medical University |
Submittted/Under Review |
| Surat Institute of digestive sciences Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Not applicable |
| Intervention |
VTX958 |
Doses 225mg, 300mg BID Orally
- Study drug should be taken by participants with approximately 240 mL (one cup) of water twice a day in the morning and evening (12 hours apart). The study drug can be taken with or without food. All doses on clinical days should be administered in
the clinic, unless otherwise indicated. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Men or women, 18 to 75 years of age, inclusive, at the time of consent
2. Capable of giving signed informed consent
3. Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
4. Moderately to severely active CD |
|
| ExclusionCriteria |
| Details |
1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
2. Presence of a stoma or ileoanal pouch
3. Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
4. Known diagnosis of short gut or bowel syndrome
5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in mean Crohns disease Activity Index (CDAI) score from baseline to week 12
2. The proportion of participants achieving endoscopic response at Week 12 |
During screening to week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in mean simple endoscopic score in Crohns disease SES-CD at Week 12
- Change from baseline in mean simple endoscopic score in Crohns disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, & presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum. |
During screening to week 12 |
Proportion of participants achieving clinical remission at Week 12
- Clinical remission is defined as a CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600. |
During screening to week 12 |
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
- The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 & unweighted CDAI component of daily average stool frequency (SF) score ≤ 3 |
During screening to week 12 |
Proportion of participants achieving clinical response at Week 12
- Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, & general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600. |
During screening to week 12 |
Proportion of participants achieving both endoscopic response (outcome- measure # 2) & clinical remission (outcome measure # 4) at Week 12
- Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12. |
During screening to week 12 |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="5"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
evaluate the efficacy and safety of VTX958 (placebo, 225 mg BID, and 300 mg BID) in
participants with moderately to severely active CD. Approximately 132 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD
(yes/no). The target patient population will include: • Patients who have had an inadequate response, loss of response, or intolerance to
conventional therapy and are naïve to biologic agents (conventional treatment failed) • Patients who have had an inadequate response, loss of response, or intolerance to a
biologic agent (biologic failed). Patients in this category may have received prior
conventional therapy. It is expected that approximately 70% of participants in the study
may have had an inadequate response to biologics. The number of patients with prior
exposure to biologic therapy targeting IL-12/IL-23 (eg, ustekinumab) to be randomized
into this study will be capped at 20% of the total number of participants. |