A clinical trial to study safety and efficacy of 2 doses of SPHIRA compared to placebo in patients of psoriasis

Phase 2

Completed

• Conditions: Health Condition 1: null- Moderate to severe Psoriasis

• Registration Number: CTRI/2007/091/000003
• Lead Sponsor: icholas Piramal Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 74

Inclusion Criteria

1.Subjects of 18- 70 years of age.

2.Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months.

3.Subjects with plaque psoriasis having PASI score >10 even after at least one month treatment with topical steroids or for 2 months with other topical agents used in the treatment of psoriasis.

4.Women of childbearing potential and men agreeing to use adequate contraception

(hormonal or barrier method of birth control; abstinence) prior to entry into study, during the period of study participation and for at least 4 weeks after withdrawal from the study

5.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol-specific procedures are performed.

Exclusion Criteria

1.Subject who has received systemic therapy such as Methotrexate or Cyclosporin therapy in the past three months prior to randomization.

2.Subject who have received TNF alpha inhibitor therapy any time in the past prior to screening.

3.Subjects with spontaneously improving or rapidly deteriorating plague psoriasis, acute guttate psoriasis, pustular, inverse or erythrodermic psoriasis, Psoriatic arthritis.

4.Subject with history of cancer including skin cancer.

5.Subject with serious dermatological infection in past three months requiring systemic therapy.

6.Any condition for which participation in this study as judged by the Investigator to be detrimental to the patient, such as (but not limited to) history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric diseases

7.Subject who has uncontrolled hypertension, severe cardiovascular, pulmonary, (specially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease.

9.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs

10.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month, three months prior to screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.PASI score- change in PASI score at V4 (wk 12) compared to baseline <br/ ><br>2.Physicianâ??s Global Assessment (PGA)- Change in PGA at V2 (wk 4), V3 (wk 8) and V4 (wk12), early termination visit compared to baseline <br/ ><br>3.Photograph of the target lesionTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
1.CRP level <br/ ><br>2.Histopathological evaluation <br/ ><br>3.Gene expression profile <br/ ><br>4.ImmunohistochemistryTimepoint: 3 months