Trial Outcomes & Findings for A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease (NCT NCT05907668)
NCT ID: NCT05907668
Last Updated: 2026-08-13
Results Overview
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
At Week 24
Results posted on
2026-08-13
Participant Flow
A total of 32 participants were enrolled in the study in a proof-of-concept, open-label study that evaluated the safety and efficacy of 24 weeks of treatment with batoclimab in adults with biochemically confirmed hyperthyroidism due to Graves' disease (GD) who had failed to achieve euthyroidism on antithyroid drugs (ATDs).
The total study duration was up to 52 weeks, comprising a 4-week screening period, followed by a 24-week treatment period and a 24-week off-treatment period. Eligible participants from the 24-week treatment period entered the 24-week off-treatment period.
Participant milestones
| Measure |
Batoclimab
Participants received batoclimab 680 milligram (mg) subcutaneously (SC) injection weekly for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Batoclimab
Participants received batoclimab 680 milligram (mg) subcutaneously (SC) injection weekly for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not eligible to continue into 24 Week Follow up Period
|
4
|
Baseline Characteristics
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Baseline characteristics by cohort
| Measure |
Batoclimab
n=32 Participants
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 12.43 • n=1 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: Safety Analysis Population
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.
Outcome measures
| Measure |
Batoclimab
n=32 Participants
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline
|
68.8 percentage of participants
Interval 50.0 to 83.9
|
SECONDARY outcome
Timeframe: At Week 24Population: Safety Analysis Population
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 with ATD dose ≤50% of the baseline ATD. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was at least a 50% reduction. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.
Outcome measures
| Measure |
Batoclimab
n=32 Participants
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24
|
53.1 percentage of participants
Interval 34.7 to 70.9
|
SECONDARY outcome
Timeframe: At Week 24Population: Safety Analysis Population
Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN. Responders were defined as participants who were off ATD therapy at Week 24. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.
Outcome measures
| Measure |
Batoclimab
n=32 Participants
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Percentage of Participants Who Are Off ATD Treatment and Achieved Normalization of FT3 and FT4, or Had FT3 and/or FT4 Below the LLN at Week 24
|
31.3 percentage of participants
Interval 16.1 to 50.0
|
Adverse Events
Batoclimab
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Batoclimab
n=32 participants at risk
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Amaurosis fugax
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Endocrine ophthalmopathy
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
Other adverse events
| Measure |
Batoclimab
n=32 participants at risk
Participants received batoclimab 680 mg SC injection QW for 12 weeks, followed by 340 mg SC injection QW for 12 weeks.
|
|---|---|
|
Cardiac disorders
Aortic valve incompetence
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac failure chronic
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Extrasystoles
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Mitral valve prolapse
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Cataract
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Erythema of eyelid
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Eye pruritus
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Eye swelling
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Eyelid oedema
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Eyelid rash
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Ocular hypertension
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Eye disorders
Periorbital pain
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
5/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastritis
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Hiatus hernia
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Toothache
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Asthenia
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
34.4%
11/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Injection site erythema
|
90.6%
29/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Injection site haematoma
|
53.1%
17/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Injection site pain
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Injection site pruritus
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Injection site swelling
|
68.8%
22/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
62.5%
20/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Temperature intolerance
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Biliary colic
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
COVID-19
|
28.1%
9/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Conjunctivitis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Cystitis
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Erysipelas
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Fungal foot infection
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Gastroenteritis
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Gastrointestinal infection
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Genital herpes simplex
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Gingivitis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Herpes zoster
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Influenza
|
15.6%
5/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Nasopharyngitis
|
62.5%
20/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Onychomycosis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Oral herpes
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Periodontitis
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Rhinitis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Tooth infection
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Sports injury
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Blood albumin decreased
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Blood immunoglobulin G decreased
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Hepatic enzyme increased
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Human papilloma virus test positive
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Liver function test increased
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Investigations
Weight increased
|
25.0%
8/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Folate deficiency
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
5/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
40.6%
13/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Carotid arteriosclerosis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Cervicobrachial syndrome
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
31.2%
10/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Migraine
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
15.6%
5/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Sensory disturbance
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Depression
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Middle insomnia
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Nervousness
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Restlessness
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Sleep disorder
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Substance abuse
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal impairment
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Amenorrhoea
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
6.2%
2/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Menstrual disorder
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Vascular disorders
Haematoma
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
9.4%
3/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Vascular disorders
Peripheral venous disease
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
|
Vascular disorders
Varicose vein
|
3.1%
1/32 • Up to Week 48
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement restricting the PI's right to discuss or publish trial results for up to 18 months after trial completion.
- Publication restrictions are in place
Restriction type: OTHER