Trial Outcomes & Findings for A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS) (NCT NCT04700280)

Last Updated: 2023-09-18

Results Overview

The ESSDAI is a systemic disease activity index to assess 12 domains (organ systems: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, CNS, hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, and high). Each domain score was obtained by multiplying the activity level with the domain weight, ranged from 1 to 6, and assigned a numerical score based on pre-determined weighting of each individual domain. The sum of all individual weighted domain scores was the overall score, ranged from 0 (best) to 123 (worst activity). A higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated the improvement of symptoms. Least squares (LS) mean was calculated using mixed models for repeated measures (MMRM).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-09-18

Participant Flow

Participants were enrolled at 10 clinical study sites across 5 countries (1 in Germany, 1 in Greece, 1 in Hungary, 6 in Poland, and 1 in Ukraine).

A total of 69 participants were screened. Of these, 31 participants were randomized and treated in the study.

Participant milestones

Participant milestones
Measure	GLPG3970 Participants received GLPG3970 400 milligrams (mg) (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo Participants will receive placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Overall Study STARTED	20	11
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	11	3

Reasons for withdrawal

Reasons for withdrawal
Measure	GLPG3970 Participants received GLPG3970 400 milligrams (mg) (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo Participants will receive placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Overall Study Adverse Event	4	0
Overall Study Lack of Efficacy	1	0
Overall Study Study terminated by sponsor	5	3
Overall Study Other than specified	1	0

Baseline Characteristics

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLPG3970 n=20 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=11 Participants Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	11 Participants n=7 Participants	31 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
ESSDAI Score	12.5 score on a scale STANDARD_DEVIATION 6.6 • n=5 Participants	8.3 score on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	11.0 score on a scale STANDARD_DEVIATION 5.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Participants in the full analysis set (FAS: all randomized participants who received at least one dose of study drug) with available data were analyzed.

Outcome measures

Outcome measures
Measure	GLPG3970 n=8 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=5 Participants Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 12	-4.4 score on a scale Standard Error 1.56	-3.0 score on a scale Standard Error 2.03

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks)

Population: The safety analysis set included all randomized participants who received at least one dose of study drug.

An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) current version at the time of assessment. The maximum intensity of the AE were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). A TEAE was any AE with an onset date on or after the first dose of GLPG3970 and no later than 30 days after last dose of GLPG3970, or any worsening of any AE on or after the GLPG3970 start date.

Outcome measures

Outcome measures
Measure	GLPG3970 n=20 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=11 Participants Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity Mild	3 participants	4 participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity Moderate	5 participants	3 participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity Severe	3 participants	0 participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity Life-threatening	0 participants	0 participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity Death	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, and 12

Population: Participants in the FAS with available data were analyzed.

The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain was scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score was calculated as the mean of the 3 individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A higher score indicates worst symptom. A clinically significant reduction from baseline of the ESSPRI score (at least one point or 15% of the baseline value) indicated the improvement of symptoms.

Outcome measures

Outcome measures
Measure	GLPG3970 n=19 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=11 Participants Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12 Change at Week 4	-1.25 score on a scale Standard Error 0.37	-0.60 score on a scale Standard Error 0.49
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12 Change at Week 8	-2.05 score on a scale Standard Error 0.41	-1.28 score on a scale Standard Error 0.56
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12 Change at Week 12	-2.15 score on a scale Standard Error 0.59	-1.79 score on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, and 12

Population: Participants in the FAS with available data were analyzed.

The ESSDAI is a systemic disease activity index to assess 12 domains (organ systems: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, CNS, hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, and high). Each domain score was obtained by multiplying the activity level with the domain weight, ranged from 1 to 6, and assigned a numerical score based on pre-determined weighting of each individual domain. The sum of all individual weighted domain scores was the overall score, ranged from 0 (best) to 123 (worst activity). A higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated the improvement of symptoms. Results of Week 12 is presented in primary outcome measure 1.

Outcome measures

Outcome measures
Measure	GLPG3970 n=15 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=7 Participants Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Change From Baseline in ESSDAI Score at Weeks 4, 8, and 12 Change at Week 4	-1.7 score on a scale Standard Error 1.17	-1.4 score on a scale Standard Error 1.32
Change From Baseline in ESSDAI Score at Weeks 4, 8, and 12 Change at Week 8	-3.5 score on a scale Standard Error 1.28	-4.0 score on a scale Standard Error 2.02

SECONDARY outcome

Timeframe: Pre-dose (within 30 minutes prior to dosing) on Weeks 1, 4, 8, and 12

Population: Participants in the pharmacokinetic (PK) analysis set (all randomized participant who received at least 1 dose of study drug and for which plasma concentration data were available) with available data were analyzed.

Plasma concentration of GLPG3970 observed at pre-dose in nanogram per milliliter (ng/mL), obtained directly from the observed concentration versus time data.

Outcome measures

Outcome measures
Measure	GLPG3970 n=20 Participants Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970 Week 1	77.6 ng/mL Geometric Coefficient of Variation 64.7	—
Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970 Week 4	70.4 ng/mL Geometric Coefficient of Variation 108	—
Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970 Week 8	65 ng/mL Geometric Coefficient of Variation 265	—
Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970 Week 12	66 ng/mL Geometric Coefficient of Variation 219	—

Adverse Events

GLPG3970

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GLPG3970 n=20 participants at risk Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=11 participants at risk Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Hepatobiliary disorders Drug-induced liver injury	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.

Other adverse events

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342 900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators (PI) are NOT employed by organization sponsoring study. There IS an agreement between the PI and Sponsor (or its agents) that restricts PI's rights to discuss/publish trial results after trial is completed. Sponsor must review, approve any results of study or abstracts for professional meetings prepared by investigator(s). Published data must not compromise the objectives of study. Data from individual study centers in multicenter studies must not be published separately.
Publication restrictions are in place

Restriction type: OTHER

Measure	GLPG3970 n=20 participants at risk Participants received GLPG3970 400 mg (2 \*200 mg tablet), orally, once daily for 12 weeks.	Placebo n=11 participants at risk Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
Infections and infestations Fungal pharyngitis	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Infections and infestations Otitis media	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Infections and infestations Oral herpes	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Epstein-Barr virus antibody positive	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Lipase increased	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Pancreatic enzymes increased	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Investigations International normalised ratio increased	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	10.0% 2/20 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Oral mucosa erosion	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	5.0% 1/20 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks) The safety analysis set included all randomized participants who received at least one dose of study drug.