Psoriasis Clinical Trial
Official title:
A Randomized, Double-Blind Phase I Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Psoriasis.
The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and AUCo-t.
Patients initiated screening within 4 weeks of commencing study treatment. Based on
progression of the study, at day 0 patients were assigned to one of six treatment Cohorts.
Patients were randomized to treat all areas except the face, scalp, groin and genital areas.
Patients in Cohort 1 were treated on one side with a thin layer of active cream and the
other with placebo; in the absence of significant AEs by 14 days after the last treatment in
the Cohort escalation to the next Cohort was allowed, and each Cohort respectively.
During the treatment period patients visited the study centre weekly for safety,
tolerability and efficacy assessment. On these study visit days blood draws were done
between 7.00 and 10.00am prior to that morning's application of cream.
The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis
of stable plaque psoriasis for >months affecting a maximum of 6% of BSA with a minimum of
0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side
excluding elbow and knee.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
|
Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
|
||
| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
|
||
| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
|
N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
|
N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
|
||
| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
|
||
| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
|
Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
|
Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
|
Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
|
||
| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
|
Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
|
||
| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
|
Phase 2 |