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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part 1: Double Blind Placebo Controlled Arm 1
Participants are randomized to receive Dose 1: ABBV-2294 (combination of ABBV-722 and upadacitinib) |
Oral Tablet Oral Tablet |
|
Eksperimentel: Part 1: Double Blind Placebo Controlled Arm 2
Participants are randomized to receive Dose 2: ABBV-2294 (combination of ABBV-722 and upadacitinib) |
Oral Tablet Oral Tablet |
|
Eksperimentel: Part 1: Double Blind Placebo Controlled Arm 3
Participants are randomized to receive ABBV-722 |
Oral Tablet |
|
Eksperimentel: Part 1: Double Blind Placebo Controlled Arm 4
Participants are randomized to receive upadacitinib |
Oral Tablet |
|
Eksperimentel: Part 1: Double Blind Placebo Controlled Arm 5
Participants are randomized to receive placebo |
Oral Tablet Oral Tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1 & Part 2: Achievement of Revised Composite Response Index in Systemic Sclerosis (rCRISS)-25
Tidsramme: At Week 52
|
The rCRISS is a 2-step process wherein participants are determined to be considered as a responder or a non-responder. The first step of the rCRISS accounts for worsening or incident cases of any internal organ involvement. If the participant meets any of the Step 1 criteria, they are considered a non-responder in the trial afterwards. Step 2 includes 5 core set measures. The FVC% is evaluated to see if the change is at least 5%. The other 4 core set measures (modified Rodnan skin score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PGA) and clinician global assessment) are evaluated for change of at least 25%. A responder is a participant who has relative improvement on at least 2 of the 5 core set measures without worsening on more than 1 core set measure |
At Week 52
|
|
Part 1 & Part 2: Number of Participants Experiencing Adverse Events
Tidsramme: Up to 112 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 112 Weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1 & Part 2: Change from Baseline in Forced Vital Capacity (FVC) (mLs) in participants with interstitial lung disease (ILD) at Baseline
Tidsramme: At Week 52
|
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity. |
At Week 52
|
|
Part 1 & Part 2: Absolute change from Baseline in percent-predicted FVC in subjects with ILD at Baseline
Tidsramme: At Week 52
|
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity. |
At Week 52
|
|
Part 1 & Part 2: Change from Baseline in modified Rodnan skin score (mRSS) in all participants with mRSS score of > 10 at Baseline
Tidsramme: At Week 52
|
The mRSS is a clinical assessment tool used to evaluate skin thickness in patients with SSc, a condition characterized by skin thickening and fibrosis. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. |
At Week 52
|
|
Part 1 & Part 2: Improvement from Baseline in each of the following 3 components of the rCRISS-25 evaluated separately: FVC , mRSS and Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: At Week 52
|
|
At Week 52
|
|
Part 1 & Part 2: Change from Baseline in joint pain as assessed by the SSc Daily Diary
Tidsramme: At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in the Scleroderma Skin Patient Reported Outcome (SSPRO) physical effects domain
Tidsramme: At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: At Week 52
|
The HAQ DI is a questionnaire that determines physical function. |
At Week 52
|
|
Part 1 & Part 2: Improvement from Baseline in each of the following 2 components of the rCRISS-25 evaluated separately: PGA and CGA
Tidsramme: At Week 52
|
|
At Week 52
|
|
Part 1 & Part 2: Absolute change from Baseline in percent-predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (corrected for hemoglobin [Hb]) in participants with interstitial lung disease (ILD) at Baseline
Tidsramme: At Week 52
|
At Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M25-153
- 2026-525967-42-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD-delingstidsramme
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-delingsadgangskriterier
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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