Treating congenital ichthyosis with targeted therapy (Secukinumab)

Phase 2

• Conditions: Health Condition 1: Q803- Congenital bullous ichthyosiform erythrodermaHealth Condition 2: Q802- Lamellar ichthyosisHealth Condition 3: Q808- Other congenital ichthyosis

• Registration Number: CTRI/2022/02/040195
• Lead Sponsor: Department of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Congenital ichthyosis patients - patients with autosomal recessive congenital ichthyosis, Keratinopathic ichthyosis or Netherton syndrome- of age 6 years and older at the time of screening.

2.Confirmed diagnosis by next-generation sequencing

3.Women of child bearing potential with a negative urine pregnancy test and using adequate contraception.

4.Patients who can give valid consent.

5.Subjects must be clinically judged to be immunocompetent.

6.Subjects with no allergy to secukinumab or components of the product.

7.Subjects with normal baseline laboratory testing (CBC, HIV negative, hepatitis B, C negative, chest X ray)

Exclusion Criteria

1.Subjects < 6 years of age

2.Subjects who are unable to give informed consent or assent.

3.Subjects who have a known allergy to secukinumab.

4.Female subjects who are pregnant, considering becoming pregnant, or will breastfeed.

5.Subjects with a history of tuberculosis or immunosuppressed state

6.Subjects who have prior biologic use targeting IL-17A/IL-17 receptor A or IL-12/IL-23 or who have prior use of TNF-alpha blockers.

7.Subjects who have used a systemic retinoid within one month prior to initiation.

8.Subjects who have used topical retinoids or keratolytic within one week prior to initiation

Study & Design

• Study Type: Interventional
• Study Design: Not specified