Clinical trials: sponsored by Sun Pharmaceutical Industries Limited
Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis.
- Trial name
- reSURFACE 2 (NCT01729754)
- Testing
- Tildrakizumab 200 mg, Tildrakizumab 100 mg, Etanercept 50 mg
- Volunteers
- 1,090 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Actinic Keratosis
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for…
- Trial name
- NCT07144852
- Testing
- Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Vehicle, Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
- Where
- 22 sites in United States
- Volunteers
- 260 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Actinic Keratosis
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for…
- Trial name
- NCT07144345
- Testing
- Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%, Vehicle containing excipients only (VEH) without active ingredient, Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
- Where
- 12 sites in United States
- Volunteers
- 160 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Moderate to Severe Genital Psoriasis
A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.
- Trial name
- NCT06611163
- Testing
- Tildrakizumab 100 mg
- Where
- 56 sites in United States, Bulgaria and 3 more
- Volunteers
- 206 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Actinic Keratosis (AK)
An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face
The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a…
- Trial name
- NCT07729579
- Testing
- Investigational drug, Photodynamic therapy
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Cardiovascular Kidney Metabolic Syndrome
Cardiovascular-Kidney-Metabolic Syndrome Registry
The goal of this observational registry study is to learn about cardiovascular-kidney-metabolic syndrome, also called CKMS, among adults receiving care at tertiary care hospitals in India.
- Trial name
- CKMS Registry (NCT07718789)
- Volunteers
- 2,250 people
- Sponsor
- Centre for Chronic Disease Control, India
Acne Vulgaris
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c.
- Trial name
- NCT06415279
- Testing
- Winlevi (clascoterone) 1% cream
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Metastatic Cancer, Neoplasm, Prostate
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC.
- Conditions
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
- Trial name
- NCT05422911
- Testing
- Abiraterone acetate, Apalutamide, Enzalutamide
- Where
- 12 sites in United States
- Volunteers
- 192 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Psoriasis Vulgaris
Psoriatic Immune Response to Tildrakizumab
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.
- Trial name
- NCT05390515
- Testing
- Tildrakizumab Prefilled Syringe
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, San Francisco
Moderate-to-severe Chronic Plaque Psoriasis
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
- Trial name
- NCT03997786
- Testing
- Tildrakizumab, Etanercept
- Where
- 27 sites in United States, Hungary and 4 more
- Volunteers
- 135 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Chronic Plaque Psoriasis, Moderate to Severe Nail Psoriasis
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
- Trial name
- NCT03897075
- Testing
- Tildrakizumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 99 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Type II Diabetes Mellitus
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities.
- Trial name
- NCT07282743
- Testing
- GL0034 Dose Level 1, GL0034 Dose Level 2, GL0034 Dose Level 3
- Where
- 21 sites in United States, India
- Volunteers
- 285 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Basal Cell Carcinoma
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary…
- Trial name
- NISSO (NCT04066504)
- Testing
- sonidegib
- Where
- 47 sites in Germany, Italy and 2 more
- Volunteers
- 323 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Type II Diabetes Mellitus
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist.
- Trial name
- NCT07385547
- Testing
- GL0034
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries Limited
Active Psoriatic Arthritis
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
- Trial name
- NCT04314531
- Testing
- TILD
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 296 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Psoriatic Arthritis
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
An open label phase 3 study
- Trial name
- NCT04991116
- Testing
- TILD sub-cutaneous (SC) injection
- Where
- 99 sites in United States, Australia and 12 more
- Volunteers
- 529 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Alopecia Areata
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
- Trial name
- NCT07133308
- Testing
- Deuruxolitinib
- Where
- 64 sites in United States, Canada
- Volunteers
- 355 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Acne Vulgaris
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment
- Trial name
- NCT06425900
- Testing
- Winlevi (Clascoterone) cream 1%
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Pregnancy Related
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.
- Trial name
- NCT03992729
- Testing
- Pregnant women exposed to tildrakizumab, Pregnant women not exposed to tildrakizumab
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Moderate to Severe Plaque Psoriasis
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
- Trial name
- SOLARES-PsO-1 (NCT04566666)
- Testing
- SCD-044_Low Dose (Dose 1), SCD-044_Intermediate Dose (Dose 2), SCD-044_High Dose (Dose 3)
- Where
- 50 sites in United States, El Salvador and 3 more
- Volunteers
- 263 people
- Sponsor
- Sun Pharmaceutical Industries Limited