Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Spesolimab

• Registration Number: NCT02978690
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Study Start: 2016-12-19
• Primary Completion: 2017-09-20
• Study Completion: 2018-01-10
• Status Verified: 2022-09
• Results First Submitted: 2022-09-26
• Results First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spesolimab	Spesolimab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Adverse Reactions, Defined as Drug-related Adverse Events (AE)	Up to 140 days from the administration of spesolimab.	Percentage of patients with adverse reactions, defined as drug-related Adverse Events is presented.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at Week 2	At baseline and at Week 2.	Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale scale score at Week 2 is presented.; The FACIT-Fatigue scale is a brief and reliable instrument for monitoring fatigue and its effects on patients. It is a comprehensive compilation of questions that measure health-related quality of life in patients with chronic illnesses. It comprises 13 questions, the responses to which are each recorded on a 5-point Likert scale. Scores range from 0 to 52, with lower scores representing greater fatigue, i.e. higher changes from baseline indicate higher improvement (compared to baseline)
Proportion of Patients With Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Total Score of 0 (Clear) or 1 (Almost Clear) at Week 2	At Week 2.	GPPGA relies on clinical assessment of the GPP patient's skin presentation. It is a modified Physician Global Assessment (PGA), a physician's assessment of psoriatic lesions, which has been adapted to the evaluation of GPP patients.; The investigator (or qualified site personnel) scores the erythema, pustules and scaling of all psoriatic lesions from 0 - 4. Each component is graded separately, the average is calculated and the final GPPGA is determined from this composite score. A lower score then indicates a lesser severity, with 0 being clear and 1 being almost clear. To receive a score of 0 or 1, the patient should be afebrile, in addition to skin presentation requirements.
Area Under the Concentration-time Curve of Spesolimab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Within 1.5 hours (h) before and 0.5 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h, 312 h, 480 h, 648 h, 1992 h, 3336 h after spesolimab administration.	Area under the concentration-time curve of spesolimab in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Maximum Measured Concentration of Spesolimab in Plasma (Cmax)	Within 1.5 hours (h) before and 0.5 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h, 312 h, 480 h, 648 h, 1992 h, 3336 h after spesolimab administration.	Maximum measured concentration of spesolimab in plasma (Cmax) is reported.
Percent Change From Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Total Score at Week 2	At baseline and at Week 2.	The GPPASI is an adaptation for Generalized Pustular Psoriasis (GPP) patients of the Psoriasis Area and Severity Index (PASI), an established measure of severity and area of psoriatic lesions in patients with psoriasis. It is a tool which provides a numeric scoring for patients overall GPP disease state, ranging from 0 (no disease) to 72 (worse disease state). It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, pustules, and scaling (desquamation) over four body regions. % GPPASI change from baseline=100\* (GPPASI at baseline - GPPASI at post-baseline visit)/(GPPASI at baseline). For %GPPASI change, positive numbers show reduction in GPPASI with higher values representing a larger improvement or recovery of disease, while negative numbers show an increase in GPPASI, i.e. worsening of disease.
Change From Baseline in Pain Visual Analog Scale (VAS) Score at Week 2	At baseline and at Week 2.	The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 millimeters (mm) in length, anchored by word descriptors at each end ('no pain', 'very severe pain'). The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the 'no pain' anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity, i.e., a negative change from baseline indicates an improvement (compared to baseline).

Trial Locations

Locations (6)

Hospital Sultanah Aminah; 🇲🇾 Johor Bahru, Malaysia

HOP Saint-Louis; 🇫🇷 Paris, France

Pusan National Univ. Hosp; 🇰🇷 Busan, Korea, Republic of

Hedi Chaker Hospital, Department of Dermatology; 🇹🇳 Tunisia, Tunisia

Nagoya City University Hospital; 🇯🇵 Aichi, Nagoya, Japan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan