Trial Outcomes & Findings for A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials (NCT NCT04362254)
NCT ID: NCT04362254
Last Updated: 2025-02-24
Results Overview
Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) during maintenance treatment. The incidence rate was calculated as Incidence rate = 100 \* number of patients with TEAE / Total TEAE-specific time at risk. Where the Time at risk (for patients who experienced a TEAE) was calculated as Time at Risk (in subject years) = ((date of onset of AE - study drug start date) +1 day) / 365.25 and Time at risk (for patients who did not experience a TEAE) Time at Risk (in subject years) = ((date of the end of time at risk - study drug start date) +1 day) / 365.25.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.
Results posted on
2025-02-24
Participant Flow
This was an open-label, single group, long-term extension trial of approximately 89 weeks duration, which investigated the long-term safety and efficacy of spesolimab in patients with perianal fistulas due to Crohn's disease (CD) who had completed treatment in a parent spesolimab trial.
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
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
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|---|---|
|
Overall Study
STARTED
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12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Spesolimab
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Due to early termination of the trial
|
10
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Baseline Characteristics
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
Baseline characteristics by cohort
| Measure |
Spesolimab
n=12 Participants
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
|
|---|---|
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Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 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
|
2 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 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: First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.Population: The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) during maintenance treatment. The incidence rate was calculated as Incidence rate = 100 \* number of patients with TEAE / Total TEAE-specific time at risk. Where the Time at risk (for patients who experienced a TEAE) was calculated as Time at Risk (in subject years) = ((date of onset of AE - study drug start date) +1 day) / 365.25 and Time at risk (for patients who did not experience a TEAE) Time at Risk (in subject years) = ((date of the end of time at risk - study drug start date) +1 day) / 365.25.
Outcome measures
| Measure |
Spesolimab
n=12 Participants
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
|
|---|---|
|
Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment
|
816.6 Patients with TEAE per 100 patient years
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SECONDARY outcome
Timeframe: Baseline, week 48 and 96 of treatment.Population: The data was not collected as intended and the remission cannot be reported.
Proportion of patients with perianal fistula remission at weeks 48 and 96. Perianal fistula remission was defined as closure of all external openings, i.e. no drainage and discharge despite gentle finger compression, that were open and draining at baseline of the parent trial and closure of all external openings that were newly emerged during the parent trial or this trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 48 and 96 of treatment.Population: The data was not collected as intended and the response cannot be reported.
Proportion of patients with perianal fistula response at weeks 48 and 96. Perianal fistula response was defined as closure and no drainage and discharge despite gentle finger compression of at least 50% in number of external openings regardless of the onset time, compared with the number of open and drainage fistulas at baseline of the parent trial.
Outcome measures
Outcome data not reported
Adverse Events
Spesolimab
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spesolimab
n=12 participants at risk
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Fistula
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
Other adverse events
| Measure |
Spesolimab
n=12 participants at risk
During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks.
Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Gastrointestinal disorders
Anal polyp
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Gastrointestinal disorders
Rectal stenosis
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
General disorders
Inflammation
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
General disorders
Injection site erythema
|
25.0%
3/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
General disorders
Injection site reaction
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
General disorders
Injection site swelling
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
COVID-19
|
50.0%
6/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Fungal infection
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Otitis media
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Infections and infestations
Pustule
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Injury, poisoning and procedural complications
Seroma
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
16.7%
2/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Psychiatric disorders
Panic attack
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
2/12 • First dose of Spesolimab through to the last dose of Spesolimab + 16 weeks, up to 105 weeks.
The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
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