To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (SOLARES-PsO-1)

Sun Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: Placebo; Drug: SCD-044_Dose 3; Drug: SCD-044_Dose 1; Drug: SCD-044_Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04566666

SCD-044-19-14

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.

Full description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.
2. Aged at least 18 years.
3. Subjects with no history of active TB or symptoms of TB

Exclusion criteria

1. Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
2. Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
3. Subjects with history or presence of uveitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 4 patient groups, including a placebo group

Placebo of SCD-044 product

Placebo Comparator group

Description:

Placebo of SCD-044 study drug

Treatment:

Drug: Placebo

SCD-044 Tablets_Dose 1

Active Comparator group

Description:

SCD-044 tablets at Dose 1

Treatment:

Drug: SCD-044_Dose 1

SCD-044 Tablets_Dose 2

Active Comparator group

Description:

SCD-044 tablets at Dose 2

Treatment:

Drug: SCD-044_Dose 2

SCD-044 Tablets_Dose 3

Active Comparator group

Description:

SCD-044 tablets at Dose 3

Treatment:

Drug: SCD-044_Dose 3