Trial Outcomes & Findings for BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis (NCT NCT03648541)

Last Updated: 2025-10-17

Results Overview

Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE). The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years). Only participants receiving maintenance treatment were analysed for this endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.

Results posted on

2025-10-17

Participant Flow

An open-label 7-year long-term extension trial in patients with moderate-to-severe ulcerative colitis who completed treatment in previous spesolimab trials 1368-0005 (NCT03482635) Part 1 and 1368-0004 (NCT03100864).

Only subjects that met the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.

Participant milestones

Participant milestones
Measure	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks Participants who completed treatment in the parent trial, but did not have a clinical response at Week 12 (end of trial (EOT)), entered a 12-week spesolimab re-induction period, receiving multiple active doses of 1200 milligrams (mg) solution for infusion of spesolimab as intravenous (i.v.) infusion every 4 weeks (q4w) for 12 weeks (re-induction). If participants reached a clinical response at Week 12 of the re-induction treatment, they switched to the maintenance treatment receiving 300 mg solution of injection of spesolimab as subcutaneous (s.c.) injection q4w for up to 336 weeks. Participants who did not achieve a clinical response after 12 weeks of re-induction treatment were discontinued from treatment.	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks 300 mg solution for injection of spesolimab was administered as subcutaneous (s.c.) injection q4w for 336 weeks as maintenance treatment. This arm included participants who entered the maintenance treatment directly from the parent trial and participants who switched from the re-induction treatment. Participants who completed treatment in the parent trial and had a clinical response at week 12 (EOT) directly received maintenance treatment. Participants, who started re-induction treatment, could switch to maintenance treatment if they reached a clinical response at Week 12 of the re-induction period. Participants who experienced a disease flare during maintenance treatment were administered a single intravenous dose of spesolimab 1200 mg followed by an intensified subcutaneous maintenance dosing schedule with 600 mg q6w.
Started From Parent Trial STARTED	57	22
Started From Parent Trial COMPLETED	57	22
Started From Parent Trial NOT COMPLETED	0	0
Re-induction Period Only STARTED	57	0
Re-induction Period Only Switched to Maintenance Treatment	12	0
Re-induction Period Only COMPLETED	49	0
Re-induction Period Only NOT COMPLETED	8	0
Maintenance Period Only STARTED	0	34
Maintenance Period Only Participants From Parent Trial	0	22
Maintenance Period Only Participants From Re-induction Treatment	0	12
Maintenance Period Only COMPLETED	0	0
Maintenance Period Only NOT COMPLETED	0	34

Reasons for withdrawal

Reasons for withdrawal
Measure	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks Participants who completed treatment in the parent trial, but did not have a clinical response at Week 12 (end of trial (EOT)), entered a 12-week spesolimab re-induction period, receiving multiple active doses of 1200 milligrams (mg) solution for infusion of spesolimab as intravenous (i.v.) infusion every 4 weeks (q4w) for 12 weeks (re-induction). If participants reached a clinical response at Week 12 of the re-induction treatment, they switched to the maintenance treatment receiving 300 mg solution of injection of spesolimab as subcutaneous (s.c.) injection q4w for up to 336 weeks. Participants who did not achieve a clinical response after 12 weeks of re-induction treatment were discontinued from treatment.	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks 300 mg solution for injection of spesolimab was administered as subcutaneous (s.c.) injection q4w for 336 weeks as maintenance treatment. This arm included participants who entered the maintenance treatment directly from the parent trial and participants who switched from the re-induction treatment. Participants who completed treatment in the parent trial and had a clinical response at week 12 (EOT) directly received maintenance treatment. Participants, who started re-induction treatment, could switch to maintenance treatment if they reached a clinical response at Week 12 of the re-induction period. Participants who experienced a disease flare during maintenance treatment were administered a single intravenous dose of spesolimab 1200 mg followed by an intensified subcutaneous maintenance dosing schedule with 600 mg q6w.
Re-induction Period Only Withdrawal by Subject	1	0
Re-induction Period Only Lack of Efficacy	7	0
Maintenance Period Only Missing	0	1
Maintenance Period Only Other not listed below	0	4
Maintenance Period Only Withdrawal by Subject	0	3
Maintenance Period Only Protocol Violation	0	1
Maintenance Period Only Lack of Efficacy	0	18
Maintenance Period Only Adverse Event	0	4
Maintenance Period Only Stopped maintenance treatment due to study stop	0	3

Baseline Characteristics

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spesolimab - All Patients n=79 Participants Patients with moderate-to-severe ulcerative colitis who completed treatment in previous spesolimab induction trials. Patients were treated according to their previous trial outcome. Those who completed treatment in the previous trials showing a clinical response (CR) directly received maintenance treatment, consisting of 300 mg solution for injection of spesolimab administered as subcutaneous (s.c.) injection q4w for 336 weeks. Patients who did not achieve a clinical response in the previous trials received multiple active doses of 1200 milligrams (mg) solution for infusion of spesolimab as intravenous (i.v.) infusion every 4 weeks (q4w) for 12 weeks, as re-induction treatment. If participants reached a clinical response at Week 12 of the re-induction treatment, they switched to the maintenance treatment receiving 300 mg solution of injection of spesolimab as subcutaneous (s.c.) injection q4w for up to 336 weeks.
Age, Continuous	43.0 Years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	11 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	2 Participants n=5 Participants
Race (NIH/OMB) White	65 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 maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.

Population: SAF-MT: All participants who received at least one dose of maintenance treatment in this extension trial. Only participants receiving maintenance treatment were analysed for this endpoint.

Outcome measures

Outcome measures
Measure	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks n=34 Participants 300 mg solution for injection of spesolimab was administered as subcutaneous (s.c.) injection q4w for 336 weeks as maintenance treatment. This arm included participants who entered the maintenance treatment directly from the parent trial and participants who switched from the re-induction treatment. Participants who completed treatment in the parent trial and had a clinical response at week 12 (EOT) directly received maintenance treatment. Participants, who started re-induction treatment, could switch to maintenance treatment if they reached a clinical response at Week 12 of the re-induction period. Participants who experienced a disease flare during maintenance treatment were administered a single intravenous dose of spesolimab 1200 mg followed by an intensified subcutaneous maintenance dosing schedule with 600 mg q6w.
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)	260.6 Events per 100 patient-years

SECONDARY outcome

Timeframe: Up to 336 weeks

Population: Since this trial was prematurely ended and no patient achieved the Week 336 visit, no data satisfied the reporting criteria, and the endpoint could not be analysed.

Proportion of patients with clinical remission at Week 336 of maintenance treatment. Clinical remission was defined as rectal bleeding score (RBS) = 0, modified endoscopic subscore \[mESS\] ≤1, stool frequency score (SFS) = 0 or 1 and drop ≥1 from baseline, and modified mayo clinical score ((MCS) ≤2).

Outcome measures

Outcome data not reported

Adverse Events

1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks

Serious events: 6 serious events

Other events: 24 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks n=57 participants at risk Participants who completed treatment in the parent trial, but did not have a clinical response at Week 12 (end of trial (EOT)), entered a 12-week spesolimab re-induction period, receiving multiple active doses of 1200 milligrams (mg) solution for infusion of spesolimab as intravenous (i.v.) infusion every 4 weeks (q4w) for 12 weeks (re-induction). If participants reached a clinical response at Week 12 of the re-induction treatment, they switched to the maintenance treatment receiving 300 mg solution of injection of spesolimab as subcutaneous (s.c.) injection q4w for up to 336 weeks. Participants who did not achieve a clinical response after 12 weeks of re-induction treatment were discontinued from treatment.	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks n=34 participants at risk 300 mg solution for injection of spesolimab was administered as subcutaneous (s.c.) injection q4w for 336 weeks as maintenance treatment. This arm included participants who entered the maintenance treatment directly from the parent trial and participants who switched from the re-induction treatment. Participants who completed treatment in the parent trial and had a clinical response at week 12 (EOT) directly received maintenance treatment. Participants, who started re-induction treatment, could switch to maintenance treatment if they reached a clinical response at Week 12 of the re-induction period. Participants who experienced a disease flare during maintenance treatment were administered a single intravenous dose of spesolimab 1200 mg followed by an intensified subcutaneous maintenance dosing schedule with 600 mg q6w.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Endocrine disorders Adrenal insufficiency	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Gastrointestinal disorders Colitis ulcerative	3.5% 2/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	5.9% 2/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Infections and infestations COVID-19 pneumonia	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Infections and infestations Gastroenteritis	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Infections and infestations Upper respiratory tract infection	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	2.9% 1/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.
Vascular disorders Deep vein thrombosis	1.8% 1/57 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.	0.00% 0/34 • Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days. (SAF-RT): All participants who received at least on dose of re-induction treatment in this extension trial; (SAF-MT): All participants who received at least on dose of maintenance treatment in this extension trial. Arms are not mutually exclusive.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 18002430127

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