Trial · NCT04527380
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
NCT04527380, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2025-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis. Trials, record NCT04527380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04527380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
- NCT number
- NCT04527380
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- Interventions
- Ixekizumab, Adalimumab
- First posted
- 2020-08-26
- Last updated
- 2026-08-12
- Other registries' IDs
- eudract:2018-000681-10
- Results first posted
- 2025-06-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) | Week 16 | JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%. |
| Secondary | Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period) | Week 16 | JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%. |
| Secondary | Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Week 16 | JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR 50/70/90 response is defined as a greater than or equal to (≥) 50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%. |
| Secondary | Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period) | Week 104 | JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR 30/50/70/90 response is defined as a greater than or equal to (≥) 30/50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%. |
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLT Period) | Baseline, Week 16 | The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none 1. = slight 2. = moderate 3. = severe 4. = very severe The various body regions are weighted to reflect their respective proportion of BSA. |
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLE Period) | Baseline, Week 104 | The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none 1. = slight 2. = moderate 3. = severe 4. = very severe The various body regions are weighted to reflect their respective proportion of BSA. |
| Secondary | Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period) | Baseline, Week 16 | The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. |
| Secondary | Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLE Period) | Baseline, Week 104 | The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. |
| Secondary | Percentage of Participants With Disease Flare (OLT Period) | Week 2 through Week 16 | Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). |
| Secondary | Percentage of Participants With Disease Flare (OLE Period) | Baseline through Week 104 | Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) | Week 16 | All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period) | Week 16 | All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Week 16 | All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period) | Week 104 | |||
| SECONDARY | Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLT Period) | Baseline, Week 16 | All randomized participants who received at least one dose of study drug with baseline psoriatic lesion(s) involving ≥3% BSA. For missing post-baseline values for subjects who discontinued the study drug due to adverse events, imputation was performed using the Modified Baseline Observation Carried Forward (mBOCF) method. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLE Period) | Baseline, Week 104 | |||
| SECONDARY | Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period) | Baseline, Week 16 | All randomized participants who received at least one dose of study drug and had a baseline enthesitis (LEI \>0). For missing post-baseline values for subjects who discontinued the study drug due to adverse events, imputation was performed using the Modified Baseline Observation Carried Forward (mBOCF) method. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLE Period) | Baseline, Week 104 | |||
| SECONDARY | Percentage of Participants With Disease Flare (OLT Period) | Week 2 through Week 16 | All randomized participants, even if the participant does not take the assigned treatment. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Flare (OLE Period) | Baseline through Week 104 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) | Ixekizumab - OLT Period | 88.9 | Percentage of participants | ||
| Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period) | Adalimumab - OLT Period | 95.0 | Percentage of participants | ||
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Ixekizumab - OLT Period | ACR50 response | 79 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Adalimumab - OLT Period | ACR50 response | 90.0 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Ixekizumab - OLT Period | ACR70 response | 64.2 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Adalimumab - OLT Period | ACR70 response | 65.0 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Ixekizumab - OLT Period | ACR90 response | 29.6 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Adalimumab - OLT Period | ACR90 response | 40.0 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Ixekizumab - OLT Period | ACR100 response | 18.5 | Percentage of participants | |
| Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period) | Adalimumab - OLT Period | ACR100 response | 35.0 | Percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixekizumab - OLT Period | 81 | |
| Overall Study | STARTED | Adalimumab - OLT Period | 20 | |
| Overall Study | Received at Least One Dose of Study Drug | Ixekizumab - OLT Period | 81 | |
| Overall Study | Received at Least One Dose of Study Drug | Adalimumab - OLT Period | 20 | |
| Overall Study | COMPLETED | Ixekizumab - OLT Period | 80 | |
| Overall Study | COMPLETED | Adalimumab - OLT Period | 19 | |
| Overall Study | NOT COMPLETED | Ixekizumab - OLT Period | 1 | |
| Overall Study | NOT COMPLETED | Adalimumab - OLT Period | 1 |
Source ClinicalTrials.gov
Adverse events348
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Ixekizumab - OLT Period | 1 | 81 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Adalimumab - OLT Period | 0 | 20 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ixekizumab - OLT Period | 1 | 81 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Adalimumab - OLT Period | 0 | 20 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Ixekizumab - OLT Period | 1 | 81 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Adalimumab - OLT Period | 0 | 20 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Ixekizumab - OLT Period | 0 | 81 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Adalimumab - OLT Period | 1 | 20 | 1 |
| other | Ear inflammation | Ear and labyrinth disorders | Ixekizumab - OLT Period | 0 | 81 | 0 |
| other | Ear inflammation | Ear and labyrinth disorders | Adalimumab - OLT Period | 1 | 20 | 1 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab - OLT Period | 0 | 81 |
| Total, all-cause mortality | Adalimumab - OLT Period | 0 | 20 |
| Total, other adverse events | Ixekizumab - OLT Period | 66 | 81 |
| Total, other adverse events | Adalimumab - OLT Period | 15 | 20 |
| Total, serious adverse events | Ixekizumab - OLT Period | 3 | 81 |
| Total, serious adverse events | Adalimumab - OLT Period | 3 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41785908 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ixekizumab - OLT Period vs Adalimumab - OLT Period: deaths from any cause | Trial comparisons |
| Ixekizumab - OLT Period vs Adalimumab - OLT Period: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04527380
GET https://conductscience.org/api/trials/v1/NCT04527380/results?page=2