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Clinical Trials associated with ABBV-722 / Not yet recruitingPhase 2/3 A Phase 2b/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABBV-2294 (Combination of ABBV-722 and Upadacitinib) in Adult Patients With Systemic Sclerosis
Systemic sclerosis (SSc), also called scleroderma, is a rare long-term autoimmune disease that causes the body to make too much collagen (scar tissue), leading to hard, thick skin and sometimes damage to organs such as the lungs, heart, kidneys, or digestive system. An autoimmune disease is a condition where the body's immune system, which normally protects against germs, mistakenly attacks its own healthy tissues and organs.
The study has 2 parts. The main goal of Part 1 is to evaluate the safety and efficacy (how well the study treatment works) of ABBV-2294 (combination of ABBV-722 and upadacitinib) in adult participants with SSc that are currently receiving local standard of care treatment, and to determine the best dose of ABBV-2294 to be evaluated further. The main goal of Part 2 is to evaluate the safety and efficacy of the dose of ABBV-2294 determined in Part 1 when compared to placebo (looks like the study treatment but has no medicine in it) in adult patients with SSc that are currently receiving local standard of care treatment. Participants will undergo trial-related procedures throughout the study which may include physical exams, questionnaires, scans and imaging, and blood and urine tests.
ABBV-2294 (combination of ABBV-722 and upadacitinib) is an investigational drug being developed for the treatment of SSc in adult participants. At the start of Part 1, participants will be randomly assigned to receive Dose 1 of ABBV-722 and upadacitinib given together, Dose 2 of ABBV-722 and upadacitinib given together, ABBV-722 given alone, upadacitinib given alone, or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 56-week extension period.
Participants that join Part 2 will be randomly assigned to receive either ABBV-2294 (dose determined in Part 1) or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 104-week extension period. All participants that join the extension will receive ABBV-2294.
Participants 18 years of age and older diagnosed with Systemic sclerosis (SSc). Around 580 participants will be enrolled at approximately 200 sites worldwide.
Participants will receive upadacitinib and/or ABBV-722 oral tablets (or matching placebo) for 52 weeks in Part 1 with an optional 56-week extension period. Part 2 participants will receive ABBV-2294 (dose determined in Part 1) or matching placebo for 52 weeks with an optional 104-week extension period of open label ABBV-2294 (dose determined in Part 1).
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
/ Not yet recruitingPhase 2 A Phase 2b, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function. Synovial fibroblasts play a key role in RA pathogenesis, with treatment-refractory patients demonstrating increased numbers of these cells. The goal of this study is to evaluate the safety and effectiveness of ABBV-2294 (a combination of ABBV-722 and upadacitinib) compared to each drug alone in treating moderately to severely active RA. The platform study will measure improvements in disease activity using the American College of Rheumatology (ACR) criteria, changes in disease activity scores, and quality of life measures.
ABBV-2294 is an investigational combination drug being developed for the treatment of moderately to severely active rheumatoid arthritis. This is a Phase 2b, randomized, double-blind platform study. In sub-study 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment consisting of either ABBV-722 alone, upadacitinib alone, or various doses of ABBV-722 combined with upadacitinib. Adult participants with a diagnosis of moderately to severely active rheumatoid arthritis who have failed at least 1 prior biologic disease-modifying antirheumatic drug (bDMARD) will be enrolled. Around 250 participants will be enrolled in the study at multiple sites worldwide.
Participants will receive oral tablet doses of ABBV-2294 (combination of ABBV-722 and upadacitinib), ABBV-722 alone, or upadacitinib alone. The study comprises a 24-week Double-Blind Phase (Period 1) followed by an optional 52-week Blinded Long Term Extension Phase (Period 2), for a total treatment duration of up to 76 weeks. After completing treatment, participants will have a 30-day Follow-Up Period.
Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits through Week 76, followed by a follow-up visit. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of ABBV-722 in Healthy Adult Subjects
The objective of this study is to assess the effect of repeated doses of itraconazole on the single dose pharmacokinetics (PK) of ABBV-722.
100 Clinical Results associated with ABBV-722
100 Translational Medicine associated with ABBV-722
100 Patents (Medical) associated with ABBV-722
100 Deals associated with ABBV-722
