Trial Outcomes & Findings for A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa (NCT NCT04762277)

Last Updated: 2025-10-17

Results Overview

Percent change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percent change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported.

Results posted on

2025-10-17

Participant Flow

This was an international, phase IIa multi-center, double-blind, placebo-controlled trial assessing the efficacy and safety of spesolimab in patients with moderate to severe Hidradenitis suppurativa (HS).

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

Participant milestones
Measure	Placebo Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Overall Study STARTED	17	35
Overall Study COMPLETED	16	32
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Overall Study Withdrawal by Subject	0	2
Overall Study Protocol Violation	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=17 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=35 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Total n=52 Participants Total of all reporting groups
Age, Continuous	34.1 Years STANDARD_DEVIATION 11.0 • n=5 Participants	35.7 Years STANDARD_DEVIATION 11.3 • n=7 Participants	35.2 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	29 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	23 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Total number of abscesses and inflammatory nodules	18.9 abscesses and inflammatory nodules STANDARD_DEVIATION 15.7 • n=5 Participants	11.6 abscesses and inflammatory nodules STANDARD_DEVIATION 9.3 • n=7 Participants	14.0 abscesses and inflammatory nodules STANDARD_DEVIATION 12.1 • n=5 Participants

PRIMARY outcome

Timeframe: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported.

Population: Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. Data up to use of rescue therapy were included for analysis, and data post the use were censored. Only patients with non-missing endpoint data were included.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=30 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12	-34.7 percent change Standard Error 11.1	-38.8 percent change Standard Error 7.5

SECONDARY outcome

Timeframe: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported.

Percent change from baseline in draining fistula at Week 12 was calculated as: \[(total draining fistula at Week 12) - (total draining fistula at baseline)\] \* 100 %/ (total draining fistula at baseline). Percent change from baseline in draining fistula count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=24 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Percent Change From Baseline in Draining Fistula Count at Week 12	56.6 percent change Standard Deviation 23.0	-40.1 percent change Standard Deviation 16.8

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 12.

Population: Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. Any binary data collected after use of any rescue therapy was censored and then imputed using the no response imputation (NRI) method as described in the statistical analysis plan.

HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Proportion of patients with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Proportion of patients with achievement of HiSCR at Week 12 was calculated as: number of patients with achievement of HiSCR at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=35 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	0.176 proportion of patients	0.314 proportion of patients

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.

The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules \* 1 + number of abscesses \* 2 + number of draining fistula \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Absolute change from baseline in IHS4 value at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=30 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 12	4.9 units on a scale Standard Error 4.7	-9.0 units on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported in the table below.

HASI includes four domains to assess the severity of HS disease activity, which are erythema, induration, open ulcer and draining fistula and scored on a Likert scale 0 (none) to 3 (severe/extensive) for each predetermined body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the patient's BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90- 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) derive from MMRM.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=30 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at Week 12	-3.8 units on a scale Standard Error 6.9	-23.6 units on a scale Standard Error 4.7

SECONDARY outcome

Timeframe: At Week 12.

HS-PGA documents the physician's assessment of the patient's HS at a given timepoint. The HS-PGA score ranges from 0 to 5, where: 0=clear - no abscesses, draining fistula, inflammatory nodules or noninflammatory nodules); 1=minimal - no abscesses, draining fistula or inflammatory nodules and the presence of noninflammatory nodules); 2=mild - no abscesses or draining fistula and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules); 3=moderate - no abscesses or draining fistula and ≥5 inflammatory nodules, or 1 abscess or draining fistula and ≥1 inflammatory nodule, or 2-5 abscesses or draining fistula and \<10 inflammatory nodules); 4=severe - 2-5 abscesses or draining fistula and ≥10 inflammatory nodules); 5=very severe - \>5 abscesses or draining fistula). Proportion of patients with achievement of HS-PGA score of 0 or 1 at Week 12 was calculated as: number of patients with achievement of HS-PGA score of 0 or 1 at Week 12/number of patients analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=35 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 at Week 12	0.000 proportion of patients	0.057 proportion of patients

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 12.

The HS Pain Numerical Rating Scale (NRS) is an endpoint for the assessment of HS-related pain severity. Recall period is 24 hours and response is given by an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). For the analysis of pain, weekly average of daily assessment was calculated for each visit based on values prior to the visit. Missing daily values within a week were ignored if there are at least 4 reported values. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12 was calculated as: number of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=35 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain at Week 12	0.059 proportion of patients	0.229 proportion of patients

SECONDARY outcome

Timeframe: Baseline (Week 0) and at Week 12.

Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 is reported. Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 was calculated as: number of patients with occurrence of complete elimination of draining fistulas at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=28 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Occurrence of Complete Elimination of Draining Fistulas at Week 12	0.067 proportion of patients	0.250 proportion of patients

SECONDARY outcome

Timeframe: At Week 12.

Proportion of patients with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Proportion of patients with occurrence of at least one flare at Week 12 was calculated as: number of patients with occurrence of at least one flare at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=35 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Occurrence of at Least One Flare at Week 12	0.176 proportion of patients	0.086 proportion of patients

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in DLQI from baseline to Week 12 is reported.

The DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Response categories include "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 with higher scores indicating greater health-related quality of life impairment. Absolute change from baseline in DLQI score at Week 12 was modelled using MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 4, 8, and 12).

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=30 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12	-2.8 units on a scale Standard Error 1.8	-2.8 units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in HiS-QoL from baseline to Week 12 is reported.

HiS-QoL is a patient-administered, 17-item instrument to measure HS-specific quality of life in clinical trials with a 7-day recall period. The 17-item HiS-QoL included four symptom items, eight activity-adaptation items and five psychosocial items. The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on health-related quality of life. Absolute change from baseline in HiS-QoL total score at Week 12 was modelled using MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 4, 8, and 12).

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=25 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Absolute Change From Baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total Score at Week 12	-4.5 units on a scale Standard Error 3.2	-5.8 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Up to 12 weeks for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)) and up to 28 weeks who did not roll-over to the OLE trial. For details please see description.

Population: Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. One patient randomised to receive placebo took spesolimab during the study, therefore was considered in spesolimab arm instead for safety reporting.

Percentage of patients with occurrence of Treatment Emergent Adverse Events (TEAEs) is reported. Percentage of patients with occurrence of Treatment Emergent Adverse Events (TEAEs) was calculated as: number of patients with occurrence of TEAEs / number of patients analyzed. Percentages were rounded to one decimal place. Time Frame: From first drug administration until 16 weeks after last drug administration, up to 28 weeks for patients who did not to roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). From first drug administration until Week 12 for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=36 Participants Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
The Occurrence of Treatment Emergent Adverse Events (TEAEs)	87.5 percentage of patients	77.8 percentage of patients

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Spesolimab

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=16 participants at risk Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.	Spesolimab n=36 participants at risk Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10.
Psychiatric disorders Suicidal behaviour	6.2% 1/16 • From first drug administration until 16 weeks after last drug administration, up to 28 weeks for patients who did not to roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). From first drug administration until Week 12 for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. One patient randomised to receive placebo took spesolimab during the study, therefore was considered in spesolimab arm instead for safety reporting.	0.00% 0/36 • From first drug administration until 16 weeks after last drug administration, up to 28 weeks for patients who did not to roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). From first drug administration until Week 12 for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. One patient randomised to receive placebo took spesolimab during the study, therefore was considered in spesolimab arm instead for safety reporting.

Other adverse events

Additional Information

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Boehringer Ingelheim

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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.
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