Trial Outcomes & Findings for A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032 (NCT NCT04086121)
NCT ID: NCT04086121
Last Updated: 2025-02-24
Results Overview
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.
TERMINATED
PHASE2
14 participants
From first dose until Week 48, up to 48 weeks.
2025-02-24
Participant Flow
This open label extension clinical trial was planned to offer all patients who completed the clinical trial 1368-0032 (NCT03822832) as planned, the option to continue to receive BI 655130 treatment if they have responded to treatment and meet all criteria for study entry.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Spesolimab 600 mg
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Spesolimab 600 mg
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Overall Study
Other than listed
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
Baseline characteristics by cohort
| Measure |
Spesolimab 600 mg
n=14 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until Week 48, up to 48 weeks.Population: Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.
Outcome measures
| Measure |
Spesolimab 600 mg
n=14 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
|
9 Participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 48.Population: Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score.
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%.
Outcome measures
| Measure |
Spesolimab 600 mg
n=9 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48
|
-3.74 Percent change
Standard Deviation 81.99
|
SECONDARY outcome
Timeframe: At baseline and at Week 48.Population: Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score.
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 50%, then EASI50 = 1.
Outcome measures
| Measure |
Spesolimab 600 mg
n=9 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 48.Population: Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score.
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 75%, then EASI75 = 1.
Outcome measures
| Measure |
Spesolimab 600 mg
n=9 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48
|
22.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 48.Population: Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score.
The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is.
Outcome measures
| Measure |
Spesolimab 600 mg
n=9 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48
|
-10.07 Score on a scale
Standard Deviation 66.04
|
SECONDARY outcome
Timeframe: At baseline and at Week 48.Population: Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score.
The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment.
Outcome measures
| Measure |
Spesolimab 600 mg
n=9 Participants
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48
|
22.2 Percentage of participants
|
Adverse Events
Spesolimab 600 mg
Serious adverse events
| Measure |
Spesolimab 600 mg
n=14 participants at risk
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Spesolimab 600 mg
n=14 participants at risk
600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks.
All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Asymptomatic COVID-19
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
14.3%
2/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tinea versicolour
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Splinter
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Investigations
Vitamin B12 decreased
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
21.4%
3/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
28.6%
4/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
7.1%
1/14 • From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER