Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib ointment 2% w/w: Tofacitinib ointment 2% w/w
shall be applied twice daily to all Atopic dermatitis areas, except those on hair-bearing scalp, at a target rate of approximat
Sponsors
Lyka Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Eligible patients shall be 18â??60 years old with a diagnosis of clinically stable AD (>= 1 month) for >= 6 months prior to the first study dose. 2. Diagnosis of AD performed by a board certified dermatologist using Hanifin and Rajka criteria at screening/washout. 3. Patients shall have a PGA score of 2 (mild) or 3 (moderate), AD covering 2â??20% of total BSA and a lichenification score body region with treatment-eligible AD. 4. AD located on the scalp, palms and soles shall be excluded from the BSA calculation used to determine eligibility. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Active forms of other dermatitides/eczematous conditions; evidence of skin conditions that would interfere with AD evaluation or treatment response. 2. AD on the groin or genitals; evidence of active, latent or inadequately treated Mycobacterium tuberculosis infection. 3. Hepatitis B/C or HIV infection; history of disseminated or recurrent herpes zoster infection; infection requiring hospitalization 4. Infection requiring oral or topical antimicrobial therapy 5. History of lymphoproliferative disorders or malignancies (except adequately treated or excised non-metastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ) or previous treatment with oral or topical Tofacitinib. 6. Patients shall be excluded who are not able to washout of treatments for AD; specifically, topical agents for >= 2 weeks prior to day 1, phototherapy or systemic therapy (immunosuppressive or cytostatic) for >= 16 weeks or corticosteroid therapy (oral or injectable) for >= 4 weeks prior to screening/washout. 7. Patients who are expected to require such therapy during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy End point: The percentage changes from baseline in the EASI total score at week 2. Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if any.Timepoint: Primary Efficacy End point: The percentage changes from baseline in the EASI total score at week 2. Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if any. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy End point: ï?· Secondary efficacy end points measured at weeks 1 and 2 including the proportion of patients with a PGA of clear or almost clear and the proportion of patients with a PGA of clear or almost clear plus â?¥ 2-point improvement from baseline. ï?· Change from baseline in EASI Clinical Signs Severity Sum Score and percentage change from baseline in BSA. ï?· The proportion of patients achieving â?¥ 50%, 75% or 90% reduction in EASI total score relative to baseline (EASI 50/75/90) shall be analyzed post hoc. ï?· The Itch Severity Item (ISI) PRO used a single 0â??10 numerical rating scale instrument to measure the change from baseline in ISI on days 2â??14 (completed by the patient at home in a diary) and at the end of week 2Timepoint: Primary Efficacy End point: The percentage changes from baseline in the EASI total score at week 2. Time-points: Baseline, Week 1/ Day 07 (±2), week 2/day 14(±2), Unscheduled visit, if any. | — |
Countries
India
Contacts
Public ContactDr Rajan Samant
Inquest Biopharm Pvt Ltd
Outcome results
None listed