Phase 2b Study to Evaluate the Efficacy and Safety of GBR 830 in Adults With Moderate to Severe Atopic Dermatitis
Status: | Recruiting |
---|---|
Conditions: | Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/2/2018 |
Start Date: | May 31, 2018 |
End Date: | April 2020 |
Contact: | Priya Raina |
Email: | clinicaltrialsdisclosuredesk@glenmarkpharma.com |
Phone: | 1-201-684-8000 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of GBR 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate
the efficacy, safety and tolerability of GBR 830 in adults with moderate to severe atopic
dermatitis.
the efficacy, safety and tolerability of GBR 830 in adults with moderate to severe atopic
dermatitis.
Inclusion Criteria:
- Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis
for >1 year as defined by American Academy of Dermatology Consensus Criteria.
- Atopic dermatitis involvement of ≥10% of body surface area and IGA score of ≥3 at
screening and baseline.
- EASI score of ≥12 at screening or ≥16 at baseline.
- IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is
moderate and 4 is severe)
- Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3
over the previous 24 hours.
Exclusion Criteria:
- Pregnant or lactating women.
- Prior treatment with GBR 830
- Treatment with biologics
- Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy
within 4 weeks of baseline
- Active chronic or acute infection requiring systemic treatment
We found this trial at
26
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials