Trial · NCT02978690
Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
NCT02978690, Phase 1, Completed, Boehringer Ingelheim; results first posted 2023-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis. Trials, record NCT02978690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02978690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
- NCT number
- NCT02978690
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Psoriasis
- Interventions
- Spesolimab
- First posted
- 2016-12-01
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2016-001236-35
- Results first posted
- 2023-08-21
- Limitations and caveats
- The results should be interpreted with caution given the limited sample size.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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) |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Adverse Reactions, Defined as Drug-related Adverse Events (AE) | Up to 140 days from the administration of spesolimab. | Treated Set (TS): All patients who entered the trial and received the trial medication on Day 1 (Visit 3). | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Total Score at Week 2 | At baseline and at Week 2. | Full Analysis Set Last Observation Carry forward (FAS LOCF). Full Analysis Set (FAS): All patients in the treated set (TS) who had a baseline and at least one post baseline GPP Area and Severity Index (GPPASI) or GPP Physician Global Assessment (GPPGA) measurement and no important protocol violation flagged for exclusion from the FAS. LOCF: The last available value, including baseline, was carried forward to all subsequent visits within the on-treatment period at which a measurement was missing. | percent GPPASI change | MEAN |
| SECONDARY | 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. | Full Analysis Set No Response Imputed (FAS NRI). Full Analysis Set (FAS): All patients in the treated set (TS) who had a baseline and at least one post baseline GPP Area and Severity Index (GPPASI) or GPP Physician Global Assessment (GPPGA) measurement and no important protocol violation flagged for exclusion from the FAS. NRI: If there were data at the visits both immediately before and immediately after the visit with a missing outcome, a failure to achieve response imputed. | proportion of patients | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at Week 2 | At baseline and at Week 2. | Full Analysis Set Last Observation Carry forward (FAS LOCF). Full Analysis Set (FAS): All patients in the treated set (TS) who had a baseline and at least one post baseline GPP Area and Severity Index (GPPASI) or GPP Physician Global Assessment (GPPGA) measurement and no important protocol violation flagged for exclusion from the FAS. LOCF: The last available value, including baseline, was carried forward to all subsequent visits within the on-treatment period at which a measurement was missing. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain Visual Analog Scale (VAS) Score at Week 2 | At baseline and at Week 2. | Full Analysis Set Last Observation Carry forward (FAS LOCF). Full Analysis Set (FAS): All patients in the treated set (TS) who had a baseline and at least one post baseline GPP Area and Severity Index (GPPASI) or GPP Physician Global Assessment (GPPGA) measurement and no important protocol violation flagged for exclusion from the FAS. LOCF: The last available value, including baseline, was carried forward to all subsequent visits within the on-treatment period at which a measurement was missing. | units on a scale | MEAN |
| SECONDARY | 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. | Pharmacokinetic (PK) parameter set (PKS): All patients in the treated set (TS) who provided at least one secondary PK endpoint not flagged for exclusion due to a protocol violation relevant to the evaluation of PK (to be decided no later than at the Report Planning Meeting) or due to PK non-evaluability (as revealed during data analysis). | microgram (μg)·day/ milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | 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. | Pharmacokinetic (PK) parameter set (PKS): All patients in the treated set (TS) who provided at least one secondary PK endpoint not flagged for exclusion due to a protocol violation relevant to the evaluation of PK (to be decided no later than at the Report Planning Meeting) or due to PK non-evaluability (as revealed during data analysis). | microgram (μg)/milliliter (mL) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Adverse Reactions, Defined as Drug-related Adverse Events (AE) | Spesolimab | 57.1 | percentage of participants | ||
| Percent Change From Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Total Score at Week 2 | Spesolimab | 73.2 | Standard Deviation 16.2 | percent GPPASI change | |
| Proportion of Patients With Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Total Score of 0 (Clear) or 1 (Almost Clear) at Week 2 | Spesolimab | 0.714 | proportion of patients | ||
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at Week 2 | Spesolimab | 12.3 | Standard Deviation 10.1 | units on a scale | |
| Change From Baseline in Pain Visual Analog Scale (VAS) Score at Week 2 | Spesolimab | -45.9 | Standard Deviation 32.3 | units on a scale | |
| Area Under the Concentration-time Curve of Spesolimab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Spesolimab | 2350 | Geometric Coefficient of Variation 41.1 | microgram (μg)·day/ milliliter (mL) | |
| Maximum Measured Concentration of Spesolimab in Plasma (Cmax) | Spesolimab | 203 | Geometric Coefficient of Variation 11.1 | microgram (μg)/milliliter (mL) |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spesolimab | 7 | |
| Overall Study | COMPLETED | Spesolimab | 7 | |
| Overall Study | NOT COMPLETED | Spesolimab | 0 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilia | Blood and lymphatic system disorders | Spesolimab | 2 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Spesolimab | 1 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Spesolimab | 1 | 7 | |
| other | Vomiting | Gastrointestinal disorders | Spesolimab | 1 | 7 | |
| other | Asthenia | General disorders | Spesolimab | 1 | 7 | |
| other | Chills | General disorders | Spesolimab | 2 | 7 | |
| other | Oedema peripheral | General disorders | Spesolimab | 2 | 7 | |
| other | Pain | General disorders | Spesolimab | 1 | 7 | |
| other | Pyrexia | General disorders | Spesolimab | 1 | 7 | |
| other | Pharyngitis | Infections and infestations | Spesolimab | 1 | 7 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab | 0 | 7 |
| Total, other adverse events | Spesolimab | 7 | 7 |
| Total, serious adverse events | Spesolimab | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39104539 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02978690
GET https://conductscience.org/api/trials/v1/NCT02978690/events?page=2