CTRI/2025/12/098446 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On:
16/06/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug Biological
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety effectiveness and Immune response of UstekiRel in 240 patients with Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and Crohns Disease
Scientific Title of Study
A prospective multicentre open label phase IV study to evaluate safety efficacy immunogenicity profile of UstekiRel in Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and Crohn's Disease
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajaykumar Yadav
Designation
AVP & Head Clinical Research Group
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group
Reliance Life Sciences
DALC Rabale Navi Mumbai- 400701 Maharashtra India
DALC R-282 TTC Area of MIDC Thane Belapur Road, Rabale Navi Mumbai – 400701 Maharashtra India Thane MAHARASHTRA 400701 India
Phone
919820804218
Fax
Email
Ajaykumar2.Yadav@relbio.com
Details of Contact Person Scientific Query
Name
Dr Sachin Kagane
Designation
Medical Monitor
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group
Reliance Life Sciences
DALC Rabale Navi Mumbai- 400701 Maharashtra India
DALC R-282 TTC Area of MIDC Thane Belapur Road, Rabale Navi Mumbai – 400701 Maharashtra India Thane MAHARASHTRA 400701 India
Phone
919987885679
Fax
Email
Sachin1.Kagane@relbio.com
Details of Contact Person Public Query
Name
Mr Ganesh Bagul
Designation
Head- Clinical Operations
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group
Reliance Life Sciences
DALC Rabale Navi Mumbai- 400701 Maharashtra India
DALC R-282 TTC Area of MIDC Thane Belapur Road, Rabale Navi Mumbai – 400701 Maharashtra India Thane MAHARASHTRA 400701 India
Phone
918104973235
Fax
Email
Ganesh1.Bagul@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt Ltd
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd
Address
Reliance Life Sciences Pvt. Ltd.,Dhirubhai Ambani Life Sciences Centre,Plot no. R-282, TTC area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai – 400710, Maharashtra, India
Amrita Institute of Medical Sciences and Research Centre
Room no: NA, Department: NA, Division: NA, Amrita lane,
Ponekkara Kochi Kerala -
682041
Ernakulam KERALA
8022024700
vinitavpanicker@aims.amrita.edu
Dr Gajanan Pise
Belagavi Institute of Medical Sciences
Room no: NA, Department: NA, Division: NA, Dr. B R Ambedkar
Road, Sadashiv Nagar
Belagavi Karnataka - 590019
Belgaum KARNATAKA
9449015444
gajananpise@gmail.com
Dr Shivakumar Patil
Bhate Hospital, Opposite civil Hospital
Room no: NA, Department: NA, Division: NA, Dr. B R Ambdekar
road Belagavi Karnataka -
590002
Belgaum KARNATAKA
9844512315
shivakumarkpatil324@gmail.com
Dr Umesh Karia
BJ Medical College and Civil Hospital
Room no: NA, Department: Department of Dermatology , STD and Leprosy, Division: NA, New Civil Hospital
Aswara Gujarat – 380016
Ahmadabad GUJARAT
8849520028
drumeshkaria@gmail.com
Dr Sonal Chavan
Calcutta School of Tropical Medicine
Room no: 108, Department: Department of Dermatology, Division: NA, Chittaranjan
Avenue, College Square
Kolkata West Bengal - 700073
Kolkata WEST BENGAL
943427717
saswatihalder32@gmail.com
Dr Geoffrey Vaz
HBT Trauma Care Hospital
Room no: NA, Department: NA, Division: NA, Ajgaokar Plot Western
Express Highway,
Jogeshwari, East Mumbai
Maharashtra - 400060
Mumbai MAHARASHTRA
8976101326
geoffry.vaz@gmail.com
Dr B L Nanjunda Swamy
K R Hospital, Attached to Mysore Medical College and Research Institute
Room no: 14, Department: Department of Dermatology, Division: NA, Irwin Road
Mysuru Karnataka -570001
Mysore KARNATAKA
9448025219
drbnlswami@gmail.com
Dr Sushil Pande
NKP Salve Institute of Medical Sciences and Research Center
Room no: NA, Department: Department of
Skin, VD and Leprosy, Division: NA, SMS Medical College
and Hospital, Charak
Bhavan, OPD Block, JLN Marg
Jaipur, Rajasthan - 302004
Jaipur RAJASTHAN
45 mg subcutaneously at week 0, 4, 16 and 28 in an open-label manner. For patients with body weight 100 kg, UstekiRel® will be administered at a dose of 90 mg at week 0, 4, 16 and 28. A single intravenous infusion using weight-based dosing at Week 0 for Inflammatory Bowel Disease (Ulcerative colitis and Crohn’s disease): 260 mg (2 vials) for weight up to 55 kg, 390 mg (3 vials) for weight greater than 55 kg and up to 85 kg, and 520 mg (4 vials) for weight greater than 85 kg, followed by a subcutaneous 90 mg dose at Week 8, 16 and 24.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Male or female between 18 and 65 years of age inclusive
Women of childbearing potential and all men must be using adequate birth control measures eg abstinence oral contraceptives intrauterine device barrier method with spermicide or surgical sterilization and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study drug
Able to adhere to the study visit schedule and other protocol requirements
Capable of giving informed consent and the consent must be obtained prior to any study related procedures
Must agree to avoid prolonged sun exposure and other ultraviolet light sources during study
Must have screening laboratory test results within acceptable limits as defined below
a Hemoglobin more than or equal to 10 g per dL
b White blood cells more than or equal to 35 x 109 per L
c Neutrophils more than or equal to 15 x 109 per L
d Platelets more than or equal to 100 x 109 per L
e Serum creatinine less than or equal to 15 mg per dL
f AST and ALT less than or equal to 2 times the upper limit of normal
g Alkaline phosphatase levels less than or equal to 2 times the upper limit of normal
Patients must be considered eligible according to the following TB screening criteria
a Have no history of latent or active TB prior to screening
b Have no signs or symptoms suggestive of active TB upon medical history and or physical examination
c Have had no recent close contact with a person with active TB or if there has been such contact patient should undergo thorough evaluation for TB prior to study enrolment
d Have no evidence of latent TB based on tuberculin skin Mantoux test QuantiFERON TB Gold test or other tuberculosis screening tests performed during screening
e Have no evidence of current active TB or old inactive TB based on chest radiograph
Plaque psoriasis
a Patients with diagnosis of plaque type psoriasis at least 6 months prior to first administration of study drug
b Patients with moderate to severe plaque psoriasis with more than or equal to 10 percentage BSA involvement and PASI score more than or equal to 12 at screening
c Patients who are potential candidates for phototherapy or systemic treatment of psoriasis
d Failed to respond to or have a contraindication to or are intolerant to other systemic therapies including ciclosporin methotrexate or PUVA psoralen and ultraviolet A
Psoriatic arthritis
a Active psoriatic arthritis more than or equal to 3 swollen joints and more than or equal to 3 tender joints in at least one of the following forms 1 distal interphalangeal DIP involvement 2 polyarticular arthritis absence of rheumatoid nodules and presence of psoriasis three arthritis mutilans
asymmetric psoriatic arthritis or 5 spondylitis like ankylosis
b Patients with plaque psoriasis with a lesion more than or equal to 2 cm in diameter
Ulcerative Colitis
a Has moderately to severely active UC defined as a Baseline Week 0 Mayo score of 6 to 12 including a screening endoscopy subscore of the Mayo score greater than or equal to more than or equal to 2 as determined by a central reading of the video endoscopy
c Has a clinical diagnosis of Ulcerative Colitis UC at least 3 months before screening
Crohns Disease
d Patients with confirmed diagnosis of Crohns disease since at least 6 months and eligible to be administered infliximab as per prescribing information of infliximab innovator
a Patients with moderate to severe active Crohn s disease defined as a Crohn s Disease Activity Index CDAI score of at least 220
ExclusionCriteria
Details
1 Patients with nonplaque forms of psoriasis eg erythrodermatic guttate or pustular
2 Patients with current druginduced psoriasis eg a new onset of psoriasis or an exacerbation of psoriasis from beta blockers calcium channel blockers or lithium
3 Pregnant nursing females or planning pregnancy both males and females during the study period until 12 months after receiving the last injection of study drug
4 Use of any therapeutic agent targeted at reducing lL12 or IL23 including but not limited to Ustekinumab
5 Patients who have received phototherapy or any systemic medications or treatments that could affect psoriasis or PASI evaluation including but not limited to oral or injectable corticosteroids retinoids 125 dihydroxy vitamin D3 and analogues psoralens sulfasalazine hydroxyurea or fumaric acid derivatives within 4 weeks prior to first administration of study drug
6 Use of topical medications or treatments that could affect psoriasis or PASI evaluation eg corticosteroids anthralin calcipotriene topical vitamin D derivatives retinoids tazarotene methoxsalen trimethylpsoralens within 2 weeks prior to first administration of study drug
7 Use of any systemic immunosuppressants eg methotrexate azathioprine cyclosporine 6thioguanine mercaptopurine mycophenolate mofetil hydroxyurea and tacrolimus within 4 weeks prior to first administration of study drug
8 Use of any biologic within the previous 3 months or 5 times the halflife of the biologic whichever is longer prior to first administration of study drug
9 Patients who have received lithium or antimalarials within 4 weeks prior to first administration of study drug
10 Patients who have received a live virus or bacterial vaccination within 3 months prior to screening Subjects must agree not to receive a live virus or bacterial vaccination during the study and up to 12 months after the last dose of study drug
11 Patients who have received a BCG vaccination within 12 months prior to screening Subject must agree not to receive a BCG vaccination during the study or up to 12 months after the last dose of study drug
12 History of chronic or recurrent infectious disease including but not limited to chronic renal infection chronic chest infection eg bronchiectasis recurrent urinary tract infection recurrent pyelonephritis or chronic nonremitting cystitis or open draining or infected skin wounds or ulcers
13 History or current evidence of a serious infection eg sepsis pneumonia or pyelonephritis within 2 months prior to screening or have been hospitalized or received IV antibiotics for an infection within 2 months prior to screening
14 History of latent or active granulomatous infection including TB histoplasmosis or coccidioidomycosis prior to screening
15 History or current evidence of a nontuberculous mycobacterial infection or opportunistic infection eg cytomegalovirus Pneumocystis carinii aspergillosis
16 History of a herpes zoster infection within 2 months prior to first administration of study drug
17 Positive HIV HBsAg or HCV test at screening
18 Current signs or symptoms of severe progressive or uncontrolled renal hepatic hematological gastrointestinal endocrine pulmonary cardiac neurologic cerebral or psychiatric disease
19 History of lymphoproliferative disease including lymphoma or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy and/or splenomegaly
20 Known history of malignancy
21 History of hypersensitivity to ustekinumab any of the excipients latex sensitivity or any immunoglobulin product eg plasma derived or recombinant monoclonal antibody
22 History of substance abuse drug or alcohol within 12 months prior to screening
23 Participation in any clinical study of an investigational product within 3 months prior to first administration of study drug
24 Has severe extensive colitis and is at imminent risk of colectomy for inflammatory bowel disease group
25 Has UC limited to the rectum only or to less than or equal to 20 centimeters cm of the colon for inflammatory bowel disease group
26 Presence of a stoma or history of a fistula for inflammatory bowel disease group
27 Participants with history of extensive colonic resection for example less than 30 cm of colon remaining that would prevent adequate evaluation of the effect of study agent on clinical disease activity for inflammatory bowel disease group
28 Has complications of Crohns disease such as symptomatic strictures or stenoses short gut syndrome or any other manifestation that might be anticipated to require surgery for inflammatory bowel disease group
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence of adverse events occurring during the study
Proportion of patients achieving PASI 50, 75, 90 and 100 response from baseline up to week 32 (Plaque Psoriasis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Proportion of patients achieving Physician Global Assessment (PGA) score of ‘cleared’ or ‘minimal’ from baseline up to week 32 (Plaque Psoriasis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Change in Dermatology Life Quality Index (DLQI) from baseline up to week 32(Plaque Psoriasis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Proportion of patients achieving DLQI score of 0 or 1 from baseline up to week 32 (Plaque Psoriasis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Immunogenicity assessment
Plaque Psoriasis; Psoriatic Arthritis: week 0, 4 and 32 or at withdrawal visit.
Ulcerative Colitis; Crohn’s Disease: week 0, 4 and 28 or at withdrawal visit.
Proportion of patients achieving the ACR 20, 50, and 70 response from baseline across visits (Psoriatic Arthritis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Proportion of patients achieving PASI 50, 75, 90 and 100 response from baseline across visits (Psoriatic Arthritis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32)
Change in HAQ-DI score from baseline across visits (Psoriatic Arthritis)
Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Number of patients with Clinical Response, Clinical Remission and Endoscopic Improvement by Mayo score (Ulcerative Colitis)
Weeks 8 and 28
Number of patients with Clinical Response (partial Mayo score: non-invasive) (Ulcerative Colitis)
Weeks 4, 8, 12, 16, 20, 24 and 28
Number of patients with Clinical Remission (partial Mayo score: non-invasive) (Ulcerative Colitis)
Weeks 4, 8, 12, 16, 20, 24 and 28
Change in faecal calprotectin levels (Ulcerative Colitis)
Weeks 8 and 28
Number of patients with Clinical Response (defined as a decrease from baseline of at least 100 points on the CDAI) _(Crohn’s Disease)
Week 8 and 28
Number of patients with Clinical Remission (Defined as a CDAI score of less than 150)_(Crohn’s Disease)
Week 8 and 28
Change in faecal calprotectin levels from baseline to week 8 and 28 _(Crohn’s Disease)
week 8 and 28
Target Sample Size
Total Sample Size="240" Sample Size from India="240" 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
Post Marketing Surveillance
Date of First Enrollment (India)
01/01/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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 prospective, multi-centre, open label, phase IV study to evaluate safety efficacy & immunogenicity profile of UstekiRel® in approved indications. In this study, a total of 240 patients with 60 patients with moderate to severe plaque psoriasis, 60 patients with moderate to severe psoriatic arthritis and 120 patients with inflammatory bowel disease (80 patients with moderate to severe ulcerative colitis and 40 patients with moderate to severe Crohn’s disease) will be enrolled to ensure 216 evaluable patients (considering a drop-out rate of 10%).