Trial · NCT01552681

Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

NCT01552681, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-03-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome. Trials, record NCT01552681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01552681

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome
NCT number: NCT01552681
Status: Terminated
Phases: Phase 2
Enrollment: 52 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Primary Sjögren's Syndrome
Interventions: Baminercept, Placebo
First posted: 2012-03-13
Last updated: 2019-01-14
Results first posted: 2016-03-23
Limitations and caveats: Randomization was prematurely stopped in July 2014 due to study product expiration. 52 of the 72 planned subjects were randomized.

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Screening in Stimulated Whole Salivary Flow at Week 24	Screening to Week 24	After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Secondary	Change From Screening in Stimulated Whole Salivary Flow at Week 48	Screening to Week 48	After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Secondary	Change From Screening in Unstimulated Whole Salivary Flow at Week 24	Screening to Week 24	The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Secondary	Change From Screening in Unstimulated Whole Salivary Flow at Week 48	Screening to Week 48	The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Secondary	Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24	Baseline to Week 24	The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Secondary	Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24	Week 24	Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Secondary	Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48	Week 48	Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Secondary	Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24	Week 24	On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Secondary	Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48	Week 48	On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Secondary	Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24	Week 24	Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Screening in Stimulated Whole Salivary Flow at Week 24	Screening to Week 24	The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.	mL/min	MEAN
SECONDARY	Change From Screening in Stimulated Whole Salivary Flow at Week 48	Screening to Week 48	The Modified Intent-to-Treat with available data population included all randomized subjects who received \>=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).	mL/min	MEAN
SECONDARY	Change From Screening in Unstimulated Whole Salivary Flow at Week 24	Screening to Week 24	The Modified Intent-to-Treat with available data population included all randomized subjects who received \>=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).	mL/min	MEAN
SECONDARY	Change From Screening in Unstimulated Whole Salivary Flow at Week 48	Screening to Week 48	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.	mL/min	MEAN
SECONDARY	Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24	Baseline to Week 24	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.	units on a scale	MEAN
SECONDARY	Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24	Week 24	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.	Percent of participants	NUMBER
SECONDARY	Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48	Week 48	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.	Percent of participants	NUMBER
SECONDARY	Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24	Week 24	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.	mm	MEAN
SECONDARY	Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48	Week 48	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.	mm	MEAN
SECONDARY	Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24	Week 24	The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.	mm	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Screening in Stimulated Whole Salivary Flow at Week 24	Baminercept 100 mg	0.0	Standard Deviation 0.3	mL/min
Change From Screening in Stimulated Whole Salivary Flow at Week 24	Placebo	0.1	Standard Deviation 0.2	mL/min
Change From Screening in Stimulated Whole Salivary Flow at Week 48	Baminercept 100 mg	0.0	Standard Deviation 0.3	mL/min
Change From Screening in Stimulated Whole Salivary Flow at Week 48	Placebo	-0.1	Standard Deviation 0.2	mL/min
Change From Screening in Unstimulated Whole Salivary Flow at Week 24	Baminercept 100 mg	0.1	Standard Deviation 0.2	mL/min
Change From Screening in Unstimulated Whole Salivary Flow at Week 24	Placebo	0.1	Standard Deviation 0.1	mL/min
Change From Screening in Unstimulated Whole Salivary Flow at Week 48	Baminercept 100 mg	0.1	Standard Deviation 0.1	mL/min
Change From Screening in Unstimulated Whole Salivary Flow at Week 48	Placebo	0.1	Standard Deviation 0.1	mL/min
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24	Baminercept 100 mg	-1.1	Standard Deviation 2.3	units on a scale
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24	Placebo	-0.4	Standard Deviation 3.1	units on a scale

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Baminercept 100 mg	33
Overall Study	STARTED	Placebo	19
Overall Study	COMPLETED	Baminercept 100 mg	28
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	Baminercept 100 mg	5
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events88

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Baminercept 100 mg	8	33	17
other	Anaemia	Blood and lymphatic system disorders	Placebo	3	19	3
other	Leukopenia	Blood and lymphatic system disorders	Baminercept 100 mg	3	33	3
other	Leukopenia	Blood and lymphatic system disorders	Placebo	2	19	3
other	Lymphopenia	Blood and lymphatic system disorders	Baminercept 100 mg	8	33	11
other	Lymphopenia	Blood and lymphatic system disorders	Placebo	4	19	7
other	Neutropenia	Blood and lymphatic system disorders	Baminercept 100 mg	4	33	7
other	Neutropenia	Blood and lymphatic system disorders	Placebo	5	19	7
other	Thrombocytopenia	Blood and lymphatic system disorders	Baminercept 100 mg	2	33	2
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	1	19	1

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Baminercept 100 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Baminercept 100 mg	33	33
Total, other adverse events	Placebo	18	19
Total, serious adverse events	Baminercept 100 mg	5	33
Total, serious adverse events	Placebo	1	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29604186	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Baminercept 100 mg vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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