Trial · NCT03129100
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
NCT03129100, Phase 3, Completed, Eli Lilly and Company; results first posted 2021-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis. Trials, record NCT03129100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03129100
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
- NCT number
- NCT03129100
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 773 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Axial Spondyloarthritis
- Interventions
- Ixekizumab, Placebo
- First posted
- 2017-04-26
- Last updated
- 2022-06-13
- Other registries' IDs
- eudract:2016-002634-69
- Results first posted
- 2021-06-18
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) | Week 64 | A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. |
| Secondary | Percentage of Participants Who do Not Experience a Flare | Week 64 | A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. |
| Secondary | Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | Baseline, 2 Years | The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge. By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 \[no change\] to 72 \[progression\]. |
| Secondary | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response | Week 64 | ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. The following ASAS domains are used: Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 \& Q6 (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe). |
| Secondary | Percentage of Participants Achieving an ASAS40 Response | Week 64 | ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used: Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 \& Q6 (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe). |
| Secondary | Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units | Week 64 | ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness +0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. |
| Secondary | Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units) | Week 64 | ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. |
| Secondary | Change From Baseline in the Individual Components of the ASAS Criteria | Baseline, Week 64 | Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. |
| Secondary | Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response | Week 64 | The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline. |
| Secondary | Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) | Baseline, Week 64 | High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who do Not Experience a Flare | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | Baseline, 2 Years | Ixekizumab structure population who have been treated with ixekizumab for at least 24 months. | Units on a Scale | MEAN |
| SECONDARY | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an ASAS40 Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units) | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Individual Components of the ASAS Criteria | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | milligram per liter (mg/L) | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) | Combined IXE | 83.3 | Percentage of participants | ||
| Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) | Placebo | 54.7 | Percentage of participants | ||
| Percentage of Participants Who do Not Experience a Flare | IXE80Q4W | 83.3 | Percentage of participants | ||
| Percentage of Participants Who do Not Experience a Flare | IXE80Q2W | 83.3 | Percentage of participants | ||
| Percentage of Participants Who do Not Experience a Flare | Placebo | 54.7 | Percentage of participants | ||
| Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | IXE80Q4W | 0.41 | Standard Deviation 2.102 | Units on a Scale | |
| Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | IXE80Q2W | 0.23 | Standard Deviation 1.387 | Units on a Scale | |
| Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | Combined IXE | 0.32 | Standard Deviation 1.779 | Units on a Scale | |
| Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response | IXE80Q4W | 81.3 | Percentage of participants | ||
| Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response | IXE80Q2W | 81.5 | Percentage of participants |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow598
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-In Period (Period 1) | STARTED | IXE 80Q4W-Lead-in Period | 350 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q2W-Lead-in Period | 423 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q4W-Group A Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q2W-Group A Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q4W-Group B-Randomized Withdrawal Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q2W-Group B-Randomized Withdrawal Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | Placebo-Group B-Randomized Withdrawal Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q2W/IXE80Q2W-Retreatment Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | IXE80Q4W/IXE80Q4W-Retreatment Extension Period | 0 | |
| Lead-In Period (Period 1) | STARTED | PBO/IXE80Q2W-Retreatment Extension Period | 0 |
1 to 10 of 598Source ClinicalTrials.gov
See all 598 participant flowAdverse events2,782
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 | Leukopenia | Blood and lymphatic system disorders | IXE 80Q4W-Lead-in Period | 1 | 348 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q2W-Lead-in Period | 0 | 423 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q4W-Group A Extension Period | 0 | 255 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q2W-Group A Extension Period | 2 | 318 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q4W-Group B-Randomized Withdrawal Extension Period | 0 | 47 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q2W-Group B-Randomized Withdrawal Extension Period | 0 | 54 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo-Group B-Randomized Withdrawal Extension Period | 0 | 53 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q2W/IXE80Q2W-Retreatment Extension Period | 0 | 6 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IXE80Q4W/IXE80Q4W-Retreatment Extension Period | 1 | 5 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | PBO/IXE80Q2W-Retreatment Extension Period | 0 | 9 | 0 |
1 to 10 of 2,782Source ClinicalTrials.gov
See all 2,782 adverse eventsAdverse event totals78
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IXE 80Q4W-Lead-in Period | 0 | 348 |
| Total, all-cause mortality | IXE80Q2W-Lead-in Period | 0 | 423 |
| Total, all-cause mortality | IXE80Q4W-Group A Extension Period | 2 | 255 |
| Total, all-cause mortality | IXE80Q2W-Group A Extension Period | 0 | 318 |
| Total, all-cause mortality | IXE80Q4W-Group B-Randomized Withdrawal Extension Period | 0 | 47 |
| Total, all-cause mortality | IXE80Q2W-Group B-Randomized Withdrawal Extension Period | 0 | 54 |
| Total, all-cause mortality | Placebo-Group B-Randomized Withdrawal Extension Period | 0 | 53 |
| Total, all-cause mortality | IXE80Q2W/IXE80Q2W-Retreatment Extension Period | 0 | 6 |
| Total, all-cause mortality | IXE80Q4W/IXE80Q4W-Retreatment Extension Period | 0 | 5 |
| Total, all-cause mortality | PBO/IXE80Q2W-Retreatment Extension Period | 0 | 9 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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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