Trial · NCT03334435
A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
NCT03334435, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-07-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis. Trials, record NCT03334435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03334435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
- NCT number
- NCT03334435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,645 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Atopic Dermatitis
- Interventions
- Baricitinib, Placebo
- First posted
- 2017-11-07
- Last updated
- 2024-09-03
- Other registries' IDs
- eudract:2017-000873-35
- Results first posted
- 2022-07-01
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | Weeks 16, 36 and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. |
| Primary | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. |
| Secondary | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. |
| Secondary | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Weeks 16, 36, and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. |
| Secondary | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36 and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. |
| Secondary | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. |
| Secondary | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. |
| Secondary | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. |
| Secondary | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Weeks 16, 36, and 52 Weeks | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75. |
| Secondary | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Weeks 16, 36, and 52 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | Weeks 16, 36 and 52 | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
| PRIMARY | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
| SECONDARY | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
| SECONDARY | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
| SECONDARY | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36 and 52 | Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population. | Percentage of participants | NUMBER |
| SECONDARY | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population. | Percentage of participants | NUMBER |
| SECONDARY | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, 52 | Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population. | Percentage of participants | NUMBER |
| SECONDARY | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population. | Percentage of participants | NUMBER |
| SECONDARY | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Weeks 16, 36, and 52 Weeks | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
| SECONDARY | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Weeks 16, 36, and 52 | Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population. | Percentage of participants | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group310
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Placebo | Week 16 | 36.5 | 95% Confidence Interval 24.8 to 50.1 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 1-mg | Week 16 | 46.7 | 95% Confidence Interval 32.9 to 60.9 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 2-mg | Week 16 | 59.3 | 95% Confidence Interval 46.0 to 71.3 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 4-mg | Week 16 | 48.6 | 95% Confidence Interval 37.2 to 60.0 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Placebo | Week 36 | 23.1 | 95% Confidence Interval 13.7 to 36.1 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 1-mg | Week 36 | 31.1 | 95% Confidence Interval 19.5 to 45.7 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 2-mg | Week 36 | 63.0 | 95% Confidence Interval 49.6 to 74.6 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 4-mg | Week 36 | 37.1 | 95% Confidence Interval 26.8 to 48.9 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Placebo | Week 52 | 28.8 | 95% Confidence Interval 18.3 to 42.3 | Percentage of participants |
| Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 | RPR-Bari 1-mg | Week 52 | 35.6 | 95% Confidence Interval 23.2 to 50.2 | Percentage of participants |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 results by groupParticipant flow150
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1: Week 0 to Week 52 | STARTED | Placebo | 91 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | Baricitinib (Bari) 1- Milligram (mg) | 45 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | Bari 2-mg | 519 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | Bari 4-mg | 743 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | Bari 2-mg Open-Label Addendum | 247 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | 2 mg Bari to Placebo Substudy | 0 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | 2 mg Bari to 1 mg Bari Substudy | 0 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | 2 mg Bari to 2 mg Bari Substudy | 0 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | 4 mg Bari to Placebo Substudy | 0 | |
| Treatment Period 1: Week 0 to Week 52 | STARTED | 4 mg Bari to 2 mg Bari Substudy | 0 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 participant flowAdverse events1,918
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 | Pyrexia | General disorders | Placebo | 0 | 91 | 0 |
| other | Pyrexia | General disorders | Bari 1-mg | 2 | 45 | 2 |
| other | Pyrexia | General disorders | Bari 2-mg | 17 | 766 | 18 |
| other | Pyrexia | General disorders | Bari 4-mg | 19 | 743 | 20 |
| other | Pyrexia | General disorders | 2 mg Bari to Placebo Substudy | 0 | 92 | 0 |
| other | Pyrexia | General disorders | 2 mg Bari to 1 mg Bari Substudy | 0 | 91 | 0 |
| other | Pyrexia | General disorders | 2 mg Bari to 2 mg Bari Substudy | 1 | 92 | 1 |
| other | Pyrexia | General disorders | 4 mg Bari to Placebo Substudy | 0 | 84 | 0 |
| other | Pyrexia | General disorders | 4 mg Bari to 2 mg Bari Substudy | 1 | 84 | 1 |
| other | Pyrexia | General disorders | 4 mg Bari to 4 mg Bari Substudy | 2 | 84 | 2 |
1 to 10 of 1,918Source ClinicalTrials.gov
See all 1,918 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 91 |
| Total, all-cause mortality | Bari 1-mg | 0 | 45 |
| Total, all-cause mortality | Bari 2-mg | 0 | 766 |
| Total, all-cause mortality | Bari 4-mg | 1 | 743 |
| Total, all-cause mortality | 2 mg Bari to Placebo Substudy | 1 | 92 |
| Total, all-cause mortality | 2 mg Bari to 1 mg Bari Substudy | 0 | 91 |
| Total, all-cause mortality | 2 mg Bari to 2 mg Bari Substudy | 0 | 92 |
| Total, all-cause mortality | 4 mg Bari to Placebo Substudy | 0 | 84 |
| Total, all-cause mortality | 4 mg Bari to 2 mg Bari Substudy | 0 | 84 |
| Total, all-cause mortality | 4 mg Bari to 4 mg Bari Substudy | 0 | 84 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers6
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.
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/NCT03334435
GET https://conductscience.org/api/trials/v1/NCT03334435/registered?page=2