Trial Outcomes & Findings for Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis (NCT NCT03622658)
NCT ID: NCT03622658
Last Updated: 2022-03-08
Results Overview
The primary endpoint was the proportion of subjects who achieved an Assessment in Ankylosing Spondylitis with 20% improvement (ASAS20) clinical response at Week 12. An ASAS20 clinical response was defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0 to 100 scale in at least three of the following four domains collected in the electronic case report form (eCRF) and no worsening in the fourth domain: Subject's Global Assessment of Disease Status, Subject's Assessment of Spinal Pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) and inflammation (last two questions of the BASDAI). Lower values within the individual domains represent less severe symptoms.
COMPLETED
PHASE2
42 participants
Weeks 12
2022-03-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
36
|
|
Overall Study
COMPLETED
|
3
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
Total
n=42 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
|
6 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Height
|
175.5 cm
n=5 Participants
|
173.5 cm
n=7 Participants
|
174.5 cm
n=5 Participants
|
|
Weight
|
86.5 kg
n=5 Participants
|
80.5 kg
n=7 Participants
|
82.15 kg
n=5 Participants
|
|
BMI
|
27.85 kg/m^2
n=5 Participants
|
27.6 kg/m^2
n=7 Participants
|
27.65 kg/m^2
n=5 Participants
|
|
Prior use of anti-tumor necrosis factor (TNF) treatment
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Duration of disease <2years
|
4 participants
n=5 Participants
|
16 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 12Population: Full Analysis Set.
The primary endpoint was the proportion of subjects who achieved an Assessment in Ankylosing Spondylitis with 20% improvement (ASAS20) clinical response at Week 12. An ASAS20 clinical response was defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0 to 100 scale in at least three of the following four domains collected in the electronic case report form (eCRF) and no worsening in the fourth domain: Subject's Global Assessment of Disease Status, Subject's Assessment of Spinal Pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) and inflammation (last two questions of the BASDAI). Lower values within the individual domains represent less severe symptoms.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
The Proportion of Subjects Who Achieved ASAS20 Clinical Response
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set.
Proportion of subjects who achieved Assessment in Ankylosing Spondylitis with 40% improvement (ASAS40) response at Week 12
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set.
Proportion of subjects who achieved an ASAS20 clinical response at Week 6
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
|
0 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set. Overall number of participants analyzed reflect those with available ASDAS-CRP Scores as reported in the final clinical study report.
Proportion (percentage) of subjects who achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) response at Week 6, Clinically Important Improvement
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=33 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set. Overall number of participants analyzed reflect those with available ASDAS-CRP Scores as reported in the final clinical study report.
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12, Clinically Important Improvement
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=32 Participants
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
|
1 Participants
|
10 Participants
|
Adverse Events
Placebo
Namilumab
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 participants at risk
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Placebo: Placebo solution for subcutaneous injection.
|
Namilumab
n=36 participants at risk
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Namilumab: Namilumab solution for subcutaneous injection
|
|---|---|---|
|
Blood and lymphatic system disorders
Macrocytosis
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 28 weeks
|
19.4%
7/36 • 28 weeks
|
|
Gastrointestinal disorders
Frequent bowel movement
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
16.7%
1/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 28 weeks
|
25.0%
9/36 • 28 weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
|
Infections and infestations
Otitis externa
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 28 weeks
|
8.3%
3/36 • 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 28 weeks
|
8.3%
3/36 • 28 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Nervous system disorders
Hypoaethesia
|
0.00%
0/6 • 28 weeks
|
8.3%
3/36 • 28 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 28 weeks
|
8.3%
3/36 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • 28 weeks
|
8.3%
3/36 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
16.7%
1/6 • 28 weeks
|
2.8%
1/36 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 28 weeks
|
5.6%
2/36 • 28 weeks
|
|
Infections and infestations
Infected cyst
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
|
Investigations
Protein urine present
|
16.7%
1/6 • 28 weeks
|
0.00%
0/36 • 28 weeks
|
Additional Information
Dr. Simon Lowry, Chief Medical Officer
Kinevant Sciences Inc. on behalf of Kinevant Science GmbH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place