Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
NCT02978690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-08-21
Summary
This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of spesolimab in adult patients with active Generalized Pustular Psoriasis (GPP).
Conditions
Interventions
- DRUG
-
Spesolimab
Solution for infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-19
- Primary Completion
- 2017-09-20
- Completion
- 2018-01-10
Countries
- France
- Japan
- Malaysia
- South Korea
- Taiwan
- Tunisia
Study Locations
More Related Trials
-
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
NCT03135548 ·Status: COMPLETED ·Phase: PHASE2
-
An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
NCT05239039 ·Status: COMPLETED ·Phase: PHASE3
-
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
NCT01519089 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
NCT01988103 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
NCT06295692 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
NCT06506916 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
NCT01925768 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
NCT02931838 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
NCT01680159 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03598790 ·Status: COMPLETED ·Phase: PHASE3
-
Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis
NCT01736696 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
NCT00399906 ·Status: COMPLETED ·Phase: PHASE2
-
BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT03000075 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
NCT05352893 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
NCT01690299 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
NCT02425826 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)
NCT03766685 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
NCT02595970 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
NCT05223868 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
NCT02326298 ·Status: COMPLETED ·Phase: PHASE3
-
Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
NCT01577550 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02850965 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
NCT03619902 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
NCT03051217 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
NCT06176508 ·Status: RECRUITING ·Phase: PHASE2