Colitis, UlcerativePhase 2/3NCT03482635

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

A Phase 2/3 study testing Spesolimab in people with Colitis, Ulcerative, run by Boehringer Ingelheim at 54 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colitis, Ulcerative
What is being tested?: Spesolimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 54 sitesin 12 countries
Study dates: 27 Mar 2018to 18 May 2020
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 - 75 years, at date of signing informed consent, males or females
Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
Further inclusion criteria apply

Who cannot join

Evidence of abdominal abscess at screening
Evidence of fulminant colitis or toxic megacolon at screening
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
Further exclusion criteria apply

Trial locations and contacts

54 sites in 12 countries.

Country

City, postcode or hospital

54 sites in 12 countries

United States13 sites

Emory University
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60637
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Baylor College of Medicine
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
AdventHealth Orlando
Orlando, Florida, 32803
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092

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Japan9 sites

Toho University Sakura Medical Center
Chiba, Sakura, 285-8741
Sapporo Tokushukai Hospital
Hokkaido, Sapporo, 004-0041
Sapporo Higashi Tokushukai Hospital
Hokkaido, Sapporo, 065-0033
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, 663-8501
Sameshima Hospital
Kagoshima, Kagoshima, 892-0846
Ofuna Chuo Hospital
Kanagawa, Kamakura, 247-0056
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku, 113-8519
Kitasato Institute Hospital
Tokyo, Minato-ku, 108-8642
Tokyo Yamate Medical Center
Tokyo, Shinjuku, 169-0073

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Germany7 sites

Universitätsklinikum Aachen, AöR
Aachen, 52074
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Essen AöR
Essen, 45147
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Universitätsklinikum Ulm
Ulm, 89081

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Russia6 sites

FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
Irkutsk, 664003
Kirov State Med.Univ. of MoH RF
Kirov, 610027
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
Moscow, 123423
Reg. Clin. Scientific Research Institute na Vladimiskiy
Moscow, 129110
The limited liability company "Clinic USI 4D"
Pyatigorsk, 357502
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"
Saint Petersburg, 194044

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United Kingdom4 sites

Barnsley Hospital
Barnsley, S75 2EP
Doncaster Royal Infirmary
Doncaster, DN2 5LT
Guy's Hospital
London, SE1 9RT
Whiston Hospital
Prescot, L35 5DR

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Canada3 sites

Victoria Hospital (LHSC)
London, Ontario, N6A 5W9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9

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Austria2 sites

Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz, A-4010
AKH - Medical University of Vienna
Vienna, 1090

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Belgium2 sites

UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000

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Italy2 sites

Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Istituto Clinico Humanitas
Rozzano (MI), 20089

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Poland2 sites

Health Center of Mother, Child and Youth Sp.z o.o.
Warsaw, 00-632
Central Clinical Hospital MSWiA, Internal Diseases, Warsaw
Warsaw, 02-507

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South Korea2 sites

Inje University Haeundae Paik Hospital
Busan, 48108
Yeungnam University Medical Center
Daegu, 42415

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Spain2 sites

Hospital Virgen del Rocío
Seville, 41013
Hospital Politècnic La Fe
Valencia, 46026

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About this study

Official title: A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Conditions: Colitis, Ulcerative
Being tested: Spesolimab, Placebo
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpesolimabDrug
Solution for infusion
PlaceboDrug
Solution for infusion

Study groups in NCT03482635
Study group	Role	What they receive
Group 1- Placebo Group	Experimental	Not described Receives: Drug: Placebo
Group 2- Small Dose Group	Experimental	Not described Receives: Drug: Spesolimab
Group 3- Medium Dose Group	Experimental	Not described Receives: Drug: Spesolimab
Group 4 - High Dose Group	Experimental	Not described Receives: Drug: Spesolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With Clinical Remission at Week 12
Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 [if drop ≥1 from baseline] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12.
Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.
Measured: At week 12.

Secondary outcomes (4)

Proportion of Patients With Clinical Response at Week 12
Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.
Measured: At week 12.
Proportion of Patients With Endoscopic Improvement at Week 12
Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.
Measured: At week 12.
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.
Measured: At week 12.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12.
The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID).
Mean is adjusted mean.
Measured: At baseline and at week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201818 May 2020

First posted29 Mar 2018
Study start27 Mar 2018
Primary completion18 May 2020
Study completion18 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03482635
Sponsor's protocol ID: 1368-0005
Other IDs: 2017-004230-28, 2017
Status last verified: Oct 2025
First submitted: 15 Mar 2018
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy
ClinicalTrials.gov ID: NCT03482635
Acronym / sponsor ID: 1368-0005
Conditions: Colitis, Ulcerative
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 27 Mar 2018 (actual)
Primary completion: 18 May 2020 (actual)
Study completion: 18 May 2020 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 11 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1- Placebo Group	Experimental	Drug: Placebo
Group 2- Small Dose Group	Experimental	Drug: Spesolimab
Group 3- Medium Dose Group	Experimental	Drug: Spesolimab
Group 4 - High Dose Group	Experimental	Drug: Spesolimab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 - 75 years, at date of signing informed consent, males or females
Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)

Key exclusion criteria (4 listed)

Evidence of abdominal abscess at screening
Evidence of fulminant colitis or toxic megacolon at screening
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
Further exclusion criteria apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpesolimabSolution for infusion	Drug	Group 2- Small Dose Group, Group 3- Medium Dose Group, Group 4 - High Dose Group
PlaceboSolution for infusion	Drug	Group 1- Placebo Group

Primary outcome

Proportion of Patients With Clinical Remission at Week 12
Time frame: At week 12.
Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 [if drop ≥1 from baseline] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.

4 secondary outcomes

Proportion of Patients With Clinical Response at Week 12
Time frame: At week 12.
Proportion of Patients With Endoscopic Improvement at Week 12
Time frame: At week 12.
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
Time frame: At week 12.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
Time frame: At baseline and at week 12.

Results and safety

Results posted to the registry on 11 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	23	18
300 mg Spesolimab (BI 655130) SD	24	21
450 mg Spesolimab (BI 655130) q4w	23	22
1200 mg Spesolimab (BI 655130) q4w	28	20

Primary outcome: Proportion of Patients With Clinical Remission at Week 12

Time frame: At week 12.. Number (95% Confidence Interval). Unit: Proportion of Participants

Measure	Placebo n = 23	300 mg Spesolimab (BI 655130) SD n = 24	450 mg Spesolimab (BI 655130) q4w n = 23	1200 mg Spesolimab (BI 655130) q4w n = 28
Value	0.00 (0.000 to 0.143)	0.042 (0.007 to 0.202)	0.087 (0.024 to 0.268)	0.071 (0.020 to 0.226)

Placebo vs 300 mg Spesolimab (BI 655130) SD: Risk Difference (RD): 0.042 (95% CI -0.105 to 0.202)
Placebo vs 450 mg Spesolimab (BI 655130) q4w: Risk Difference (RD): 0.087 (95% CI -0.069 to 0.268)
Placebo vs 1200 mg Spesolimab (BI 655130) q4w: Risk Difference (RD): 0.071 (95% CI -0.081 to 0.226)

Population analysed: Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening until end of study, up to 29 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 23 (17.4%)	5 of 23 (21.7%)	0 of 23
300 mg Spesolimab (BI 655130) SD	3 of 24 (12.5%)	7 of 24 (29.2%)	0 of 24
450 mg Spesolimab (BI 655130) q4w	2 of 23 (8.7%)	7 of 23 (30.4%)	0 of 23
1200 mg Spesolimab (BI 655130) q4w	3 of 27 (11.1%)	17 of 27 (63%)	0 of 27

Limitations and caveats (from the sponsor): Due to recruitment issues during phase II, the trial was prematurely ended according to a protocol defined option. Phase III was not conducted. The trial was completed as defined in the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

54 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Spesolimab in people with Colitis, Ulcerative, run by Boehringer Ingelheim at 54 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Japan, Germany, Russia, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Clinical Remission at Week 12 (time frame: At week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.