A clinical trial to study the effect of Apremilast Tablets in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

A Randomized, Double-Blind, Placebo-Controlled, Comparative, Prospective, Multicentre Trial to Assess Efficacy and Safety of Apremilast Tablets in Subjects with Moderate to Severe Plaque Psoriasis who are Candidates for Phototherapy or Systemic Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007345

Enrollment

231

Registered

2016-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Moderate to Severe Plaque Psoriasis

Interventions

Intervention1: Apremilast 30 mg Tablets: administered 1 tablet twice daily for 16 weeks Control Intervention1: Placebo Tablets: administered 1 tablet twice daily for 16 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, aged >=18 years to 2. Subjects who had moderate to severe plaque psoriasis for 6 months or longer and who are candidates for phototherapy or systemic therapy.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Subjects with known hypersensitivity to the study drug or any of the excipient. 3. Subject with history of current erythrodermic, guttate or pustular psoriasis 4. Subjects with psoriasis flare or rebound within 4 weeks prior to screening 5. Subjects have used topical therapy within 2 weeks of randomization or systemic therapy or phototherapy (i.e., UVB, PUVA) for psoriasis within 28 days of randomization. 6. Subjects have used biological therapy for psoriasis within 6 months of randomization. 7. Subjects with history of malignancy (except for treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas and treated [i.e., cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence) within 5 years of screening 8. Subjects with evidence of skin conditions that would interfere with clinical assessments in the opinion of the investigator 9. Subjects with active substance abuse or a history of substance abuse within 6 months prior to Screening 10. Subjects with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections. 11. Subject who have used any investigational drug or device within 30 days of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving psoriasis area severity index - 75 responsesTimepoint: 16 weeks	—

Secondary

Measure	Time frame
1. Proportion of subjects achieving Physicianâ??s Global Assessment (PGA) score of clear (0) or almost clear (1)Timepoint: 16 weeks;2. Proportion of subjects achieving PASI-50Timepoint: 16 weeks;3. Proportion of subjects achieving PASI-90Timepoint: 16 weeks;4. Proportion of patients who have taken rescue medication during the treatment period Time-pointTimepoint: 16 weeks	—

Countries

India

Contacts

Public ContactAmol Pendse

Glenmark Pharmaceuticals Ltd

DrPiyush.Agarwal@glenmarkpharma.com912240189999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026