Trial Outcomes & Findings for A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus (NCT NCT02908100)

Last Updated: 2024-05-08

Results Overview

The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

260 participants

Primary outcome timeframe

Week 48

Results posted on

2024-05-08

Participant Flow

The study was conducted at 69 centers in 12 countries.

An overall total of 616 participants were screened into the study, of which 356 participants were screen failures. 260 participants (Intent-To-Treat/ITT population) were randomized into the study, of which 1 participant did not receive any study treatment meaning that the Safety population consisted of 259 participants.

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Overall Study STARTED	86	87	87
Overall Study COMPLETED	63	66	66
Overall Study NOT COMPLETED	23	21	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Overall Study Adverse Event	7	6	9
Overall Study Death	2	0	0
Overall Study Lack of Efficacy	2	3	3
Overall Study Lost to Follow-up	0	1	2
Overall Study Non-Compliance With Study Drug	1	1	2
Overall Study Non-Compliance With Contraceptive Method	1	0	0
Overall Study Physician Decision	0	1	0
Overall Study Pregnancy	1	2	0
Overall Study Withdrawal by Subject	8	7	5
Overall Study Randomised in Error	1	0	0

Baseline Characteristics

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	Total n=260 Participants Total of all reporting groups
Age, Continuous	40.2 Years STANDARD_DEVIATION 11.5 • n=93 Participants	43.3 Years STANDARD_DEVIATION 12.4 • n=4 Participants	40.4 Years STANDARD_DEVIATION 10.6 • n=27 Participants	41.3 Years STANDARD_DEVIATION 11.6 • n=483 Participants
Sex: Female, Male Female	85 Participants n=93 Participants	82 Participants n=4 Participants	84 Participants n=27 Participants	251 Participants n=483 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants
Race/Ethnicity, Customized Hispanic or Latino	54 Participants n=93 Participants	61 Participants n=4 Participants	61 Participants n=27 Participants	176 Participants n=483 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	32 Participants n=93 Participants	25 Participants n=4 Participants	26 Participants n=27 Participants	83 Participants n=483 Participants
Race/Ethnicity, Customized Not Stated	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska native	11 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants	36 Participants n=483 Participants
Race/Ethnicity, Customized Asian	7 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	10 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=93 Participants	15 Participants n=4 Participants	13 Participants n=27 Participants	39 Participants n=483 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Race/Ethnicity, Customized White	56 Participants n=93 Participants	62 Participants n=4 Participants	52 Participants n=27 Participants	170 Participants n=483 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.

Outcome measures

Outcome measures
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48	44.2 Percentage of Participants	50.6 Percentage of Participants	51.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.

The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].

Outcome measures

Outcome measures
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48	41.9 Percentage of Participants	50.6 Percentage of Participants	44.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.

The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].

Outcome measures

Outcome measures
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24	43.0 Percentage of Participants	47.1 Percentage of Participants	47.1 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.

Outcome measures

Outcome measures
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-4 Response at Week 24	46.5 Percentage of Participants	52.9 Percentage of Participants	52.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug. Data presented below is only for participants that were included in the actual analysis.

The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=24 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=25 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q2	54.5 Percentage of Participants	54.2 Percentage of Participants	63.2 Percentage of Participants
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q3	36.8 Percentage of Participants	52.4 Percentage of Participants	52.0 Percentage of Participants
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q1	37.5 Percentage of Participants	52.4 Percentage of Participants	45.0 Percentage of Participants
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q4	50.0 Percentage of Participants	42.9 Percentage of Participants	47.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=24 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=25 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q1	33.3 Percentage of Participants	52.4 Percentage of Participants	40.0 Percentage of Participants
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q2	54.5 Percentage of Participants	54.2 Percentage of Participants	57.9 Percentage of Participants
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q3	36.8 Percentage of Participants	52.4 Percentage of Participants	44.0 Percentage of Participants
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels Plasmablast Signature Level Q4	45.0 Percentage of Participants	42.9 Percentage of Participants	39.1 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24, 48

Population: The Intent-To-Treat (ITT) population was defined as all randomized participants regardless of whether they received any study drug.

The Systemic Lupus Erythematosus Responder Index (SRI)-6 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥6 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=86 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=87 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
SRI-6 Response at Week 24 and 48 Week 24	31.4 Percentage of Participants	34.5 Percentage of Participants	33.3 Percentage of Participants
SRI-6 Response at Week 24 and 48 Week 48	27.9 Percentage of Participants	39.1 Percentage of Participants	35.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24, 48

Population: The BICLA-evaluable population was defined as all all ITT participants who had at least one body system with moderate or severe disease activity at baseline as determined by BILAG-2004, i.e., at least one BILAG domain was scored as A or B at baseline.

The BICLA is a composite index that is defined as follows: \[1\] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; \[2\] No new BILAG A or more than one new BILAG B scores; \[3\] No worsening of total SLEDAI-2K score from baseline; \[4\] No significant deterioration (=\<10%) in physician's global assessment and \[5\] No treatment failure (initiation of non-protocol treatment).

Outcome measures

Outcome measures
Measure	Placebo n=80 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=85 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=83 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48 Week 48	41.2 Percentage of Participants	52.9 Percentage of Participants	42.2 Percentage of Participants
BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48 Week 24	47.5 Percentage of Participants	45.9 Percentage of Participants	44.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline up to 8 weeks after the last dose of study drug (up to Week 56).

Population: The Safety-evaluable population was defined as all participants who received at least one dose of study medication. One participant in the Placebo arm was inadvertently dosed with GDC-0853 for a period of 27 days and was classified as part of the GDC-0853 (200mg) BID arm.

An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=87 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID n=88 Participants Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Percentage of Participants With Adverse Events (AEs)	76.2 Percentage of Participants	88.5 Percentage of Participants	78.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)

Population: The PK-evaluable population was defined as all participants who received at least one dose of fenebrutinib (GDC-0853) and had at least 1 evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis with detectable concentrations at the specified timepoints.

The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (150mg) QD n=86 Participants Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.	GDC-0853 (200mg) BID Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 24 (8-10hr Post-dose)	120 ng/mL Standard Deviation 111	233 ng/mL Standard Deviation 145	—
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 48 (Pre-dose)	25.5 ng/mL Standard Deviation 28.1	137 ng/mL Standard Deviation 133	—
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 0 (Pre-dose)	NA ng/mL Standard Deviation NA No Drug was administered at this timepoint and so there were no detectable concentrations.	NA ng/mL Standard Deviation NA No Drug was administered at this timepoint and so there were no detectable concentrations.	—
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 24 (Pre-dose)	41.9 ng/mL Standard Deviation 62.4	180 ng/mL Standard Deviation 121	—
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 24 (2hr Post-dose)	331 ng/mL Standard Deviation 226	612 ng/mL Standard Deviation 353	—
Plasma Concentrations of Fenebrutinib at Specified Timepoints Week 24 (4-6hr Post-dose)	215 ng/mL Standard Deviation 131	414 ng/mL Standard Deviation 187	—

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 42 other events

Deaths: 2 deaths

GDC-0853 (150mg) QD

Serious events: 4 serious events

Other events: 54 other events

Deaths: 1 deaths

GDC-0853 (200mg) BID

Serious events: 12 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER