Clinical trials: sponsored by Sun Pharmaceutical Industries Limited
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
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
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
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
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
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
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
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
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
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
Active Psoriatic Arthritis
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
- Trial name
- NCT04314544
- Testing
- TILD
- Where
- 97 sites in United States, Canada and 10 more
- Volunteers
- 508 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Acne Vulgaris
A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age.
- Trial name
- NCT06415305
- Testing
- Winlevi (clascoterone) 1% cream
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Dermatitis, Atopic
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
- Trial name
- SOLARES-AD-1 (NCT04684485)
- Testing
- SCD-044_Dose 1, SCD-044_Dose 2, SCD-044_Dose 3
- Where
- 58 sites in United States, El Salvador and 3 more
- Volunteers
- 250 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Acne Vulgaris
A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in…
- Trial name
- NCT06336603
- Testing
- Winlevi (clascoterone) 1% & Adapalene 0.3% gel
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Acne Vulgaris
A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne
Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination…
- Trial name
- NCT06336629
- Testing
- Winlevi (clascoterone) 1% & Duac gel
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Acne Vulgaris
A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients
Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications…
- Trial name
- NCT06415292
- Testing
- Winlevi (clascoterone) 1% cream
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Sun Pharmaceutical Industries Limited