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
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
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
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
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
Psoriatic Arthritis
Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
- Trial name
- NCT03552276
- Testing
- SUNPG18_07 I (Tildrakizumab 200 mg), SUNPG18_07 II (Tildrakizumab 100 mg)
- Where
- 66 sites in United States, Argentina and 6 more
- Volunteers
- 281 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Osteoarthritis of Knee
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching placebo.
- Trial name
- NCT04506463
- Testing
- MM-II dose I, MM-II dose II, MM-II dose III
- Where
- 25 sites in United States, Denmark and 1 more
- Volunteers
- 397 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Dry Eye Disease
Effect of Cequa™ in Subjects With Dry Eye Disease
This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
- Trial name
- NCT04357795
- Testing
- CequaTM (Cyclosporine 0.09%) ophthalmic solution
- Where
- 5 sites in United States
- Volunteers
- 135 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Primary Open Angle Glaucoma, Ocular Hypertension
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
- Trial name
- NCT05022004
- Testing
- Brinzolamide ophthalmic suspension, Azopt®
- Where
- 40 sites in India, Russia
- Volunteers
- 599 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Scalp Psoriasis
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp.
- Trial name
- NCT03897088
- Testing
- PART 2: Double-blind Active Treatment Extension
- Where
- 25 sites in United States, Australia
- Volunteers
- 231 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Psoriasis
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects…
- Trial name
- NCT03718299
- Testing
- Injections of tildrakizumab
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Active Psoriatic Arthritis
Efficacy and Safety Study of SUNPG1623
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623
- Trial name
- NCT02980692
- Testing
- SUNPG1623 I, SUNPG1623 II, SUNPG1623 III
- Where
- United States
- Volunteers
- 391 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Keratoconjunctivitis Sicca, Dry Eye Disease
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry…
- Trial name
- NCT02254265
- Testing
- OTX-101 0.05%, OTX-101 0.09%, Vehicle
- Where
- United States
- Volunteers
- 455 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Keratoconjunctivitis Sicca
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50…
- Trial name
- Emerald (NCT02688556)
- Testing
- cyclosporine, vehicle of OTX-101
- Where
- 3 sites in United States
- Volunteers
- 745 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic…
- Trial name
- reSURFACE 1 (NCT01722331)
- Testing
- Tildrakizumab 200 mg, Tildrakizumab 100 mg
- Volunteers
- 772 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Plaque Psoriasis
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12…
- Trial name
- NCT03212963
- Testing
- Halobetasol Topical Lotion
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Sun Pharmaceutical Industries Limited