Effectiveness of different doses of apremilast in psoriasis

Efficacy and safety of different doses of apremilast in mild to moderate psoriasis: a randomized controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045573

Enrollment

123

Registered

2022-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: Apremilast 10 mg: Apremilast 10 mg BD for 4 months Intervention2: Apremilast 20 mg: Apremilast 20 mg BD for 4 months Control Intervention1: Apremilast 30 mg: Aprelimast 30 mg BD for 4 m

Eligibility

Inclusion criteria

Inclusion criteria: Psoriasis patient with: 1.Both gender aging 18-65yrs 2.Psoriasis Area and Severity Index (PASI) score 3.Body Surface Area(BSA) 4.Patients willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnant & lactating women 2.Pustular psoriasis 3.Psoriasis Area and Severity Index (PASI) score >10 4.Body Surface Area(BSA) >10% 5.Any significant medical (patient with recent MI, CHF, CRF, CLD) & surgical condition 6.Patients with significant hepatic impairment (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal) 7.Renal insufficiency - serum creatinine Ã¢â?°Â¥1.5 mg/dL (men) or Ã¢â?°Â¥1.4mg/dL (women) 8.Known hypersensitivity to Apremilast

Design outcomes

Primary

Measure	Time frame
1.To compare the efficacy (PASI, DLQI, sPGA) of Apremilast 10mg and 20mg compared to Apremilast 30mg from baseline to week 16. 2.To compare the Safety profile in all three treatment groups. Timepoint: baseline to week 16	—

Secondary

Measure	Time frame
1. To compare the efficacy and change in lipid profile parameters (Triglycerides, Total cholesterol, LDL-C, VLDL and HDL-C) in three treatment groups from baseline to week 16.Timepoint: baseline to week 16;1.To evaluate the percentage of patients having achieved PASI 90 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16 2.To evaluate the percentage of patients having achieved PASI 50 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16. Timepoint: baseline to 16 weeks;3. To evaluate the change in DLQI in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16.Timepoint: baseline to 16 weeks;4. To evaluate the change in sPGA scores in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16. 5. To evaluate the percentage of patients having achieved sPGA 0 or1 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16 weeks. Timepoint: baseline to 16 weeks;6. To evaluate the change in Psoriatic arthritis in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16.Timepoint: baseline to week 16;To evaluate the change in VAS scores for pruritus and skin discomfort in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16.Timepoint: baseline to week 16	—

Measure

Time frame

1. To compare the efficacy and change in lipid profile parameters (Triglycerides, Total cholesterol, LDL-C, VLDL and HDL-C) in three treatment groups from baseline to week 16.Timepoint: baseline to week 16;1.To evaluate the percentage of patients having achieved PASI 90 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16 2.To evaluate the percentage of patients having achieved PASI 50 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16. Timepoint: baseline to 16 weeks;3. To evaluate the change in DLQI in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mg from baseline to week 16.Timepoint: baseline to 16 weeks;4. To evaluate the change in sPGA scores in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16. 5. To evaluate the percentage of patients having achieved sPGA 0 or1 in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16 weeks. Timepoint: baseline to 16 weeks;6. To evaluate the change in Psoriatic arthritis in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16.Timepoint: baseline to week 16;To evaluate the change in VAS scores for pruritus and skin discomfort in Apremilast 30 mg versus Apremilast 20mg and Apremilast 10 mgfrom baseline to week 16.Timepoint: baseline to week 16

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Countries

India

Contacts

Public ContactAbhishek anil

AIIMS Jodhpur

drabhishekanil@gmail.com9337843755

Outcome results

None listed

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