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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: ABBVIE CALL CENTER
- Número de telefone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: Part 1: Double Blind Placebo Controlled Arm 3
Participants are randomized to receive ABBV-722 |
Oral Tablet |
|
Experimental: Part 1: Double Blind Placebo Controlled Arm 4
Participants are randomized to receive upadacitinib |
Oral Tablet |
|
Experimental: Part 1: Double Blind Placebo Controlled Arm 5
Participants are randomized to receive placebo |
Oral Tablet Oral Tablet |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1 & Part 2: Achievement of Revised Composite Response Index in Systemic Sclerosis (rCRISS)-25
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1 & Part 2: Change from Baseline in Forced Vital Capacity (FVC) (mLs) in participants with interstitial lung disease (ILD) at Baseline
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: At Week 52
|
|
At Week 52
|
|
Part 1 & Part 2: Change from Baseline in joint pain as assessed by the SSc Daily Diary
Prazo: At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in the Scleroderma Skin Patient Reported Outcome (SSPRO) physical effects domain
Prazo: At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Prazo: 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
Prazo: 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
Prazo: At Week 52
|
At Week 52
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: ABBVIE INC., AbbVie
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- M25-153
- 2026-525967-42-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critérios de acesso de compartilhamento IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
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