A Phase 3 interventional study of Dupilumab and Upadacitinib in Atopic Dermatitis, sponsored by AbbVie. Completed at 257 sites in 29 countries. Open to participants aged 12 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 920 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
Drug: Dupilumab
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
Drug: Upadacitinib
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
Drug: Upadacitinib
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
Drug: Upadacitinib
Dupilumab is administered as a subcutaneous (SC) injection.
Also known as: Dupixent®
Extended-release tablet
Also known as: ABT-494, RINVOQ
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and Week 16
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Time frame: Baseline and Week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and Week 16
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and Week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and Week 4
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and Week 2
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Time frame: Baseline and Week 4
Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Time frame: Baseline and Week 2
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Time frame: Baseline and Week 16
Participants were randomized at 214 sites located in 28 countries (Australia, Belgium, Bulgaria, Canada, China, Croatia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United States/Puerto Rico).
| Milestone | Dupilumab (Period 1) | Upadacitinib (Period 1) | Dupilumab -> Upadacitinib (Period 2) | Upadacitinib -> Upadacitinib 30 mg (Period 2) |
|---|---|---|---|---|
| Started | 462 | 458 | 0 | 0 |
| Completed | 423 | 418 | 0 | 0 |
| Not completed | 39 | 40 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 21 | 24 | 0 | 0 |
| Withdrew: Other, not specified | 16 | 16 | 0 | 0 |
| Milestone | Dupilumab (Period 1) | Upadacitinib (Period 1) | Dupilumab -> Upadacitinib (Period 2) | Upadacitinib -> Upadacitinib 30 mg (Period 2) |
|---|---|---|---|---|
| Started | 0 | 0 | 208 | 147 |
| Completed | 0 | 0 | 198 | 131 |
| Not completed | 0 | 0 | 10 | 16 |
| Withdrew: Lost to follow-up | 0 | 0 | 3 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 | 4 |
| Withdrew: Other, not specified | 0 | 0 | 4 | 11 |
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | 8.9 (6.3 to 11.5) | 19.9 (16.2 to 23.5) |
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | 22.5 (18.7 to 26.3) | 40.8 (36.3 to 45.3) |
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 | 15.5 (12.2 to 18.8) | 30.2 (26.0 to 34.4) |
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 | 38.1 (33.6 to 42.5) | 54.7 (50.1 to 59.3) |
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 | 2.8 (1.3 to 4.3) | 16.1 (12.7 to 19.5) |
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1 | 1.3 (0.3 to 2.3) | 7.7 (5.3 to 10.2) |
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 | 9.7 (7.0 to 12.4) | 23.8 (19.9 to 27.7) |
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 | 8.2 (5.7 to 10.7) | 26.7 (22.7 to 30.8) |
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
| percentage of participants | Dupilumab (Period 1) | Upadacitinib (Period 1) |
|---|---|---|
| Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 | 5.6 (3.5 to 7.7) | 14.8 (11.6 to 18.1) |
Collected over All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dupilumab (Period 1) | 0/462 (0%) | 5/462 (1.1%) | 87/462 (18.8%) |
| Upadacitinib (Period 1) | 0/458 (0%) | 4/458 (0.9%) | 156/458 (34.1%) |
| Dupilumab -> Upadacitinib (Period 2) | 0/208 (0%) | 0/208 (0%) | 57/208 (27.4%) |
| Upadacitinib -> Upadacitinib 30 mg (Period 2) | 0/147 (0%) | 4/147 (2.7%) | 30/147 (20.4%) |
| Event | Dupilumab (Period 1) | Upadacitinib (Period 1) | Dupilumab -> Upadacitinib (Period 2) | Upadacitinib -> Upadacitinib 30 mg (Period 2) |
|---|---|---|---|---|
| PNEUMONIAInfections and infestations | 1/462 | 0/458 | 0/208 | 1/147 |
| EPILEPSYNervous system disorders | 0/462 | 0/458 | 0/208 | 1/147 |
| MIGRAINE WITHOUT AURANervous system disorders | 0/462 | 0/458 | 0/208 | 1/147 |
| DERMATITIS ATOPICSkin and subcutaneous tissue disorders | 1/462 | 1/458 | 0/208 | 1/147 |
| ANAPHYLACTIC REACTIONImmune system disorders | 0/462 | 1/458 | 0/208 | 0/147 |
| MAJOR DEPRESSIONPsychiatric disorders | 0/462 | 1/458 | 0/208 | 0/147 |
| SUICIDAL IDEATIONPsychiatric disorders | 0/462 | 1/458 | 0/208 | 0/147 |
| PERIPHERAL ARTERY OCCLUSIONVascular disorders | 0/462 | 1/458 | 0/208 | 0/147 |
| DRUG-INDUCED LIVER INJURYHepatobiliary disorders | 1/462 | 0/458 | 0/208 | 0/147 |
| SEPSISInfections and infestations | 1/462 | 0/458 | 0/208 | 0/147 |
| Event | Dupilumab (Period 1) | Upadacitinib (Period 1) | Dupilumab -> Upadacitinib (Period 2) | Upadacitinib -> Upadacitinib 30 mg (Period 2) |
|---|---|---|---|---|
| NASOPHARYNGITISInfections and infestations | 35/462 | 58/458 | 18/208 | 12/147 |
| ACNESkin and subcutaneous tissue disorders | 7/462 | 55/458 | 14/208 | 5/147 |
| DERMATITIS ATOPICSkin and subcutaneous tissue disorders | 15/462 | 23/458 | 12/208 | 9/147 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 22/462 | 27/458 | 12/208 | 7/147 |
| HEADACHENervous system disorders | 16/462 | 27/458 | 5/208 | 1/147 |
Intent-to-Treat (ITT) Population of Period 1 (ITT_1 Population): all participants who were randomized at Baseline, analyzed per the treatment group to which they were randomized
| Age, Continuous(years) | Dupilumab (Period 1) | Upadacitinib (Period 1) | Total |
|---|---|---|---|
| Mean | 30.9 ± 12.79 | 31.0 ± 12.71 | 31.0 ± 12.74 |
| Sex: Female, Male(Participants) | Dupilumab (Period 1) | Upadacitinib (Period 1) | Total |
|---|---|---|---|
| Female | 217 | 195 | 412 |
| Male | 245 | 263 | 508 |
| Ethnicity (NIH/OMB)(Participants) | Dupilumab (Period 1) | Upadacitinib (Period 1) | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 44 | 85 |
| Not Hispanic or Latino | 421 | 414 | 835 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dupilumab (Period 1) | Upadacitinib (Period 1) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 137 | 122 | 259 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 19 | 20 | 39 |
| White | 296 | 303 | 599 |
| More than one race | 5 | 6 | 11 |
| Unknown or Not Reported | 2 | 2 | 4 |
Showing the first 100 of 257 sites across 29 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie