A Study to Evaluate the Safety and Efficacy (How Well the Study Treatment Works) of ABBV-2294 in Adult Participants With Systemic Sclerosis That Are Currently Receiving Local Standard of Care Treatment, and to Determine the Best Dose of ABBV-2294 to be Evaluated Further.
Run by AbbVie · NCT07933211 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2035-06.
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 upad…
Quick facts
| Phase | Phase 2/3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 580 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | ABBV-722, Upadacitinib, Placebo for ABBV-722, Placebo for Upadacitinib |
| Trial ID | NCT07933211 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any Screening or study-specific procedures. * Adults \>= 18 years of age at the time of the Screening Visit (subjects must also meet the legal age of majority per local law). * Participants are willing and able to comply with procedures required in the protocol. * Participants must not be incarcerated and must be freely willing and able to provide informed consent. Examples of subjects unable to freely provide informed consent may include some adults under legal protection measure (e.g., under guardianship/curatorship) or unable to express their consent and select adults under psychiatric care. Investigator's discretion should be applied. * Participants must fulfil the ACR/EULAR 2013 classification criteria for SSc Exclusion Criteria: * Other autoimmune connective tissue diseases, overlap syndromes, or SSc mimics (e.g., scleromyxedema, eosinophilic fasciitis), except scleroderma-associated myopathy and associated Sjögren disease. * Pulmonary disease with predicted FVC \< 45% at Screening. * Predicted diffusing capacity for carbon monoxide (DLCO, Hb corrected) \< 25% at Screening. * History of scleroderma renal crisis within the last 6 months. * History of severe gastric antral telangiectasias (watermelon stomach).
Study contacts
- Principal investigator: Abbvie INC. — AbbVie
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.