A phase III clinical trial to see how safe and effective the drug T1h mAb is in treating patients with active moderate to severe psoriasis.

A Phase III Randomized, Double Blind, Placebo Controlled, one way Crossover, Multi-Dose, Multi-center, Safety and Efficacy Study of T1h mAb administered intravenously in subjects with active moderate to severe psoriasis. Acronym TREAT-PLAQ

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001009

Enrollment

225

Registered

2010-03-25

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

None listed

Interventions

Intervention1: T1h mAb: 0.4mg/kg, 1.6mg/kg Control Intervention1: Placebo:

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-70 years Chronic plaque psoriasis for more than 1 year Involving more than 10% of body surface area Baseline PASI score ≥10 At least one lesion ≥2.5 cm2 Ability to give informed consent

Exclusion criteria

Exclusion criteria: Psoriatic Erythroderma or psoriatic crisis Pregnancy and/or breastfeeding women Significant cardiac (e.g. &#8805;NYHA III) or pulmonary disease History of or current, other inflammatory disease and/or History of chronic or current active infections History of cancer Hemoglobin < 8.0 g/dL. Absolute Neutrophil count (ANC) < 1500 cells/uL. Absolute Lymphocyte Count < 1500 cells/uL Clinical suspicion of latent tuberculosis infection or positive Mantoux test for tuberculosis

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving &#8805;PASI75 in each of the T1h mAb cohorts as compared to placeboTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Improvement in PASI and PGA scores Safety & tolerability Relapse rate QOL assessments by DLQI & SF36 Immunogenicity Exploratory Change in mNAPSI for nail psoriasis Histological improvement in Psoriasis Improvement in Psoriatic arthritis by ACR core set criteria and DAS-28 Radiological assessment of joint damage in psoriatic arthritis patients by Modified Sharp Score Timepoint: 4, 12,28 and 52 weeks	—

Measure

Time frame

Improvement in PASI and PGA scores Safety & tolerability Relapse rate QOL assessments by DLQI & SF36 Immunogenicity Exploratory Change in mNAPSI for nail psoriasis Histological improvement in Psoriasis Improvement in Psoriatic arthritis by ACR core set criteria and DAS-28 Radiological assessment of joint damage in psoriatic arthritis patients by Modified Sharp Score Timepoint: 4, 12,28 and 52 weeks

—

Countries

India

Contacts

Public ContactAbhijit Sharma

Associate Scientific Manager II

deepak.assudani@biocon.com080-28082309

Outcome results