Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 63 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Oral Tablets
• Placebo — DRUG
  Oral Tablet

Study Details

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. 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, checking for side effects and completing questionnaires.

Key Dates

Start date

Jul 25, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

1,014 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Study 1- Upadacitinib Dose A
  Participants will receive upadacitinib dose A once daily for 52 weeks.
• Placebo Comparator: Study 1- Placebo
  Participants will receive upadacitinib matching placebo once daily for 52 weeks.
• Experimental: Study 2- Upadacitinib Dose A
  Participants will receive upadacitinib dose A once daily for 52 weeks.
• Placebo Comparator: Study 2- Placebo
  Participants will receive upadacitinib matching placebo once daily for 52 weeks.
• Experimental: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
  Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
• Experimental: Study 3- Low Disease Activity Upadacitinib Dose B
  Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
• Experimental: Study 3- No LDA Upadacitinib Dose A
  Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
• Experimental: Study 3- Upadacitininb Dose A
  Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
• Experimental: Study 3- Open Label Upadacitinib Dose A
  Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
• Experimental: Study 3- Open Label Upadacitinib Dose B
  Participants who reach \>= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
• Experimental: Study 4- Upadacitinib Dose A
  Participants receiving upadacitinib Dose A in Study 3 will continue on this dose once daily for 104 weeks.
• Experimental: Study 4- Upadacitinib Dose B
  Participants receiving upadacitinib Dose B in Study 3 will continue on this dose once daily for 104 weeks.

Primary Outcome Measure

Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response [ Time Frame: At Week 52 ]

Locations (132)

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