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AbbVie Inc.

AbbVie Inc. works on 24 rare diseases tracked on Trial Friend, including Amyotrophic Lateral Sclerosis, Behçet Disease, Corticobasal Degeneration and 21 more, with 21 active clinical trials (12 recruiting) and 3 FDA-approved rare disease drugs.

AbbVie is a pharmaceutical company with a significant rare disease portfolio including rare oncology and immunology treatments. The company develops therapies for rare conditions and pursues orphan drug designations to address diseases with limited treatment options.

Type
Diversified Pharma
Ticker
ABBV
Headquarters
North Chicago, United States
Founded
2013
Website
abbvie.com
21
Active Rare Disease Trials
3
Approved Rare Disease Drugs
24
Rare Diseases in Portfolio
13
Years Active

Focus areas at AbbVie Inc.

Within its broader pharmaceutical portfolio, AbbVie Inc. has active clinical trial programs and drug development efforts across 24 rare diseases, including Amyotrophic Lateral Sclerosis, Behçet Disease, Corticobasal Degeneration, Cystic Fibrosis, Eosinophilic Esophagitis, and 19 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows active and recruiting rare disease studies sponsored by AbbVie Inc., sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

AbbVie Inc. is headquartered in North Chicago, United States, founded in 2013, publicly traded under the ticker symbol ABBV. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

AbbVie Inc. Drug Pipeline

AbbVie Inc. has 21 active clinical trials across 4 development stages, with 12 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.

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7
Early Phase / Phase 17 trials
Acute Myeloid Leukemia+1 more
Recruiting
Non-hodgkin Lymphoma
Active Not Recruiting
10
Phase 210 trials
EoE+2 more
Recruiting
Recurrent Diffuse Large B-Cell Lymphoma+4 more
Recruiting
Recruiting
3
Phase 33 trials
Juvenile Idiopathic Arthritis
Recruiting
Chronic Lymphocytic Leukemia+4 more
Active Not Recruiting
Active Not Recruiting
1
Other1 trial

AbbVie Inc. Clinical Trials (21)

Active and recruiting clinical trials sponsored by AbbVie Inc., sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

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RECRUITINGPHASE2Recently updatedNCT07588568

A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Intervention: Upadacitinib 30mg Dose, Upadacitinib Matching Placebo

The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE). The main question it aims to answer are: \- Does upadacitinib in addition to topical corticosteroids help reduce EoE disease activity? Participants will: * Take upadacitinib or placebo every day for 12 weeks, followed by 12 weeks of upadacitinib * Fill out surveys and answer health questions * Visit the clinic every 4 weeks for checkups and tests

Ages 18 Years - 65 Years2 locations
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RECRUITINGPHASE2Recently updatedNCT07231952

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Intervention: Pirtobrutinib, Venetoclax, Rituximab

The purpose of this study is to find out if the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for participants with Waldenström's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL)

Ages 18 Years+9 locations
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RECRUITINGPHASE1Recently updatedNCT07409246

A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)

Intervention: ABBV-438

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed. ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide. Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Ages 18 Years+13 locations
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RECRUITINGPHASE3Recently updatedNCT05609630

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.

Intervention: Upadacitinib, Tocilizumab

Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls 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.

Ages 1 Year - 17 Years45 locations
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RECRUITINGPHASE1, PHASE2Recently updatedNCT06953960

A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)

Intervention: Surzetoclax, Daratumumab, Dexamethasone, Pomalidomide, Etentamig

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 sites worldwide. In Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years. 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 an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Ages 18 Years+50 locations
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RECRUITINGPHASE1, PHASE2Recently updatedNCT06536049

Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Intervention: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Epcoritamab, Ibrutinib, Positron Emission Tomography

Recurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise Specified

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

Ages 18 Years+3 locations
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RECRUITINGPHASE1, PHASE2Updated a few months agoNCT07160179

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Intervention: ABBV-6628, SYFOVRE

Geographic AtrophyAge-Related Macular Degeneration

Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Ages 50 Years+5 locations
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AbbVie Inc. FDA-Approved Drugs (3)

Medications developed or marketed by AbbVie Inc. that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
ADALIMUMABHUMIRADec 31, 2002
IBRUTINIBIMBRUVICANov 13, 2013
UPADACITINIB
Janus Kinase Inhibitor [EPC]
Rinvoq
oral
Aug 16, 2019

AbbVie Inc. Trial Locations

AbbVie Inc. clinical trials are running at 652 sites in 34 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
185▼
Japan
59▼
China
48▼
Australia
45▼
France
44▼
Germany
31▼
Spain
26▼
Israel
20▼
United Kingdom
19▼
Poland
18▼
Italy
16▼
Turkey (Türkiye)
14▼

Rare Disease Focus Areas (24)

Diseases targeted by AbbVie Inc.'s clinical trial and drug development programs

Amyotrophic Lateral SclerosisNeurological & Neuromuscular

Amyotrophic lateral sclerosis is a progressive neurodegenerative disease destroying motor neurons in the brain and spinal cord. This causes progressive weakness and paralysis of voluntary muscles whil...

Prevalence: About 5,000 new cases per year in the U.S.; CDC's National ALS Registry estimates about 33,000 Americans were living with ALS in 2022, a number projected to pass 36,000 by 2030
Behçet DiseaseAutoimmune & Inflammatory

Behçet Disease is a rare, chronic, recurrent vasculitis causing painful oral and genital ulcers, eye inflammation, and skin lesions. It can affect multiple organ systems including the brain, heart, an...

Prevalence: Estimated 3-300 cases per 100,000 depending on geography; highest in Turkey (370 per 100,000), common in Middle East and East Asia, rare in North America and Northern Europe
Corticobasal DegenerationNeurological & Neuromuscular

Corticobasal degeneration is a rare neurodegenerative disorder characterized by asymmetric cortical and basal ganglia pathology with progressive motor and cognitive decline. The condition is caused by...

Prevalence: Approximately 1 in 100,000 people
Cystic FibrosisPulmonary & Respiratory

Cystic fibrosis is an autosomal recessive genetic disorder affecting the CFTR protein, which normally regulates chloride transport. Defective CFTR causes thick, sticky secretions in the lungs and dige...

Prevalence: Nearly 40,000 children and adults in the U.S.; 1 in 2,500 to 3,500 births among Caucasians
Eosinophilic EsophagitisGastrointestinal

Eosinophilic Esophagitis is a rare allergic/immune-mediated inflammatory disease of the esophagus characterized by eosinophil infiltration causing progressive narrowing and dysfunction. It presents wi...

Prevalence: Approximately 50-140 cases per 100,000 people (increasing incidence); estimated prevalence 1 in 2,000 to 1 in 400 in developed countries
Familial Medullary Thyroid CarcinomaEndocrine & Hormonal

Familial medullary thyroid carcinoma is an autosomal dominant cancer predisposition syndrome caused by germline RET mutations. Nearly all mutation carriers develop medullary thyroid cancer by adulthoo...

Prevalence: Near-complete penetrance by adulthood in RET mutation carriers (varies by specific codon mutation); comprises ~25% of medullary thyroid cancers

Patient Resources

Organizations and resources related to AbbVie Inc.'s rare disease focus areas

Frequently Asked Questions About AbbVie Inc.

Common questions about AbbVie Inc.'s rare disease programs, clinical trials, and treatments.