Adalimumab Clinical Trials

What Is Adalimumab?

Adalimumab is an FDA-approved medication for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis, and hidradenitis suppurativa. It is a fully human anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody. Adalimumab works by blocking Tumor Necrosis Factor-α (TNF-α), a key inflammatory factor, which helps to inhibit the downstream inflammatory cascade in the body and reduce inflammation in various autoimmune conditions.

Beyond its approved indications, Adalimumab is also being investigated for other conditions. Clinical trials have explored its use in inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, which are characterized by chronic inflammation of the digestive tract. Research also examines Adalimumab for uveitis, a group of diseases causing inflammation inside the eye, and for conditions like benign prostatic hyperplasia (BPH) and interstitial cystitis, which involve inflammation in the prostate and bladder, respectively. The earliest trial involving Adalimumab began on 2002-11-05, with the latest projected to conclude on 2026-05-04.

Uses and Conditions Under Study

Adalimumab has been extensively studied across a range of inflammatory and autoimmune conditions, with a total of 463 trials involving 134,928 participants. Many of these trials focus on chronic inflammatory diseases, with 30 trials currently recruiting new participants and 307 trials already completed.

• Arthritis and Spondylitis: Adalimumab is a key treatment for various forms of arthritis. For Rheumatoid Arthritis, a chronic inflammatory disorder affecting joints, there have been 115 trials. It is also studied for Psoriatic Arthritis, a type of arthritis affecting people with psoriasis, with 26 trials. Additionally, Ankylosing Spondylitis, which primarily affects the spine, has been the subject of 22 trials. Adalimumab helps by targeting the inflammatory processes that cause joint pain and stiffness in these conditions.
• Psoriasis: This chronic skin condition, characterized by red, scaly patches, is another major area of study. There have been 43 trials for Psoriasis and 16 trials specifically for Plaque Psoriasis. Adalimumab's ability to block TNF-α helps reduce skin inflammation and improve symptoms.
• Inflammatory Bowel Diseases (IBD): Adalimumab is investigated for its role in managing chronic inflammation of the digestive tract. For Crohn's Disease, which can affect any part of the digestive tract, there are 41 trials, plus an additional 17 trials listed as "Crohn Disease." Ulcerative Colitis, affecting the large intestine, has been studied in 30 trials. Adalimumab helps to reduce the uncontrolled immune response characteristic of IBD.
• Uveitis: This group of inflammatory eye diseases has been investigated in 18 trials. Adalimumab is explored for its potential to control intraocular inflammation and prevent vision loss.

Other conditions under investigation for Adalimumab include atopic dermatitis (eczema), benign prostatic hyperplasia (BPH), interstitial cystitis, sarcoidosis, and Dupuytren's disease, as indicated by various trial summaries.

Dosing

Adalimumab is primarily administered as an injection, available in various strengths and formulations. It is often provided in pre-filled syringes for self-administration. Common strengths studied include 20 mg and 40 mg, often given subcutaneously every two weeks. For example, in some trials, it was self-administered subcutaneously using a pre-filled syringe every 2 weeks for up to 2 years. Another regimen studied involved 50 mg subcutaneously weekly.

Investigational dosages have explored a wider range of strengths, such as 80 mg, 100 mg, 150 mg, 160 mg, 600 mg, and 1000 mg. Some studies also investigated weight-based dosing, such as 0.4 mg/kg or 0.8 mg/kg. While subcutaneous injection is the most common route, an intravitreal injection of Adalimumab has also been studied for specific conditions like uveitis.

For pediatric patients, Adalimumab has been studied for conditions like severe plaque psoriasis in children and adolescents aged four years and older. In these cases, specific pediatric dosing regimens are investigated to ensure safety and efficacy. The drug has also been studied in pediatric inflammatory bowel disease (IBD) patients, ranging from 1 month to 16 years of age.

Dosage forms mentioned in trials include "Adalimumab Solution for Injection 20mg/40mg" and "adalimumab injection 40 mg." The brand name Humira (adalimumab) is also frequently referenced in trial protocols.

Side Effects

The most common side effect reported in clinical trials for Adalimumab was nasopharyngitis (common cold). In one analysis of 18 trials involving 8,953 patients, 11.8% of patients taking Adalimumab experienced nasopharyngitis, compared to 6.7% on placebo.

Other common side effects included:

• Upper respiratory tract infection: In 15 trials with 8,365 patients, 10.1% of patients on Adalimumab experienced this, compared to 5.4% on placebo.
• Headache: In 16 trials with 6,849 patients, 6.5% of patients on Adalimumab reported headaches, compared to 4.7% on placebo.
• Arthralgia (joint pain): In 17 trials with 9,603 patients, 6.0% of patients on Adalimumab experienced arthralgia, compared to 3.5% on placebo.
• Urinary tract infection: In 16 trials with 8,701 patients, 5.0% of patients on Adalimumab developed a urinary tract infection, compared to 3.4% on placebo.
• Nausea: In 22 trials with 8,892 patients, 4.9% of patients on Adalimumab experienced nausea, compared to 2.7% on placebo.
• Hypertension (high blood pressure): In 15 trials with 11,497 patients, 4.3% of patients on Adalimumab experienced hypertension, compared to 2.9% on placebo.

Clinical Trial Results

Polyarticular Juvenile Idiopathic Arthritis (JIA)

In a study (NCT00048542) of children with polyarticular JIA, Adalimumab was evaluated with and without methotrexate. At the end of the double-blind phase, 17 participants receiving Adalimumab alone and 24 participants receiving Adalimumab plus methotrexate met the PedACR30 response criteria (a 30% improvement in disease activity), compared to 9 participants on placebo and 14 participants on placebo plus methotrexate. Disease flares were also less common in the Adalimumab groups; 13 participants on Adalimumab alone experienced a flare compared to 20 on placebo, and 14 participants on Adalimumab plus methotrexate flared compared to 24 on placebo plus methotrexate. Physicians' global assessment of disease activity showed an average improvement of 52.06 units for Adalimumab alone and 48.50 units for Adalimumab plus methotrexate, compared to 38.73 units for both placebo groups (lower scores indicate improvement).

Crohn's Disease

A study (NCT00055497) investigating Adalimumab for Crohn's disease showed that at Week 24, 10.2% of patients on Adalimumab 40 mg every other week and 15.6% on Adalimumab 40 mg every week achieved clinical remission, compared to 6.5% on placebo. At Week 56, 8.3% of patients on Adalimumab 40 mg every other week and 11.0% on Adalimumab 40 mg every week achieved clinical remission, compared to 5.6% on placebo. Patients treated with Adalimumab also reported greater improvements in their Inflammatory Bowel Disease Questionnaire (IBDQ) scores, with average increases of 45.7 points for every other week dosing and 45.2 points for weekly dosing, compared to 29.9 points for placebo (higher scores indicate better quality of life).

Ankylosing Spondylitis

In a trial (NCT00085644) for active ankylosing spondylitis, Adalimumab demonstrated significant improvements. 59.3% of patients on Adalimumab achieved an ASAS 20 response (a 20% improvement in disease activity), compared to 21.2% on placebo. Patients treated with Adalimumab also experienced an average improvement of approximately 3.8 cm in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) over 260 weeks, indicating reduced disease activity. Additionally, Adalimumab led to an average reduction in C-Reactive Protein (CRP) levels of approximately 1.5 mg/dL over 260 weeks, reflecting decreased inflammation.

Rheumatoid Arthritis (Long-Term)

A long-term open-label study (NCT00195650) of Adalimumab in rheumatoid arthritis showed sustained benefits. After 260 weeks, 402 participants met the ACR20 response criteria, indicating a 20% improvement in rheumatoid arthritis symptoms. Clinical remission, based on the Modified Disease Activity Score, was achieved by 243 participants at Week 260. Patients also showed an average reduction of 0.59 units in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 260, suggesting improved physical function.

Early Rheumatoid Arthritis

A study (NCT00195663) compared Adalimumab with and without methotrexate for early rheumatoid arthritis. At Week 52, 61.6% of patients treated with Adalimumab plus methotrexate achieved an ACR50 response, compared to 42.6% with Adalimumab alone and 44.4% with methotrexate alone. The combination therapy also significantly slowed joint damage progression; the average increase in Modified Total Sharp Score (mTSS) was 1.3 units for Adalimumab plus methotrexate, compared to 3.0 units for Adalimumab alone and 5.7 units for methotrexate alone (lower scores indicate less damage). Clinical remission (DAS28 score less than 2.6) at Week 52 was achieved by 43.0% of patients on Adalimumab plus methotrexate, compared to 24.2% on Adalimumab alone and 19.9% on methotrexate alone.

Currently Recruiting Trials

Adalimumab is currently being investigated in numerous clinical trials across a wide range of conditions, offering opportunities for patients to contribute to medical research. These studies explore new uses, compare adalimumab with other treatments, or investigate ways to optimize its use.

For individuals with Type 1 Diabetes, a Phase 1/2 trial (NCT07061574) is recruiting 120 participants aged 9 to less than 21 years with new-onset disease. This study evaluates low-dose anti-thymocyte globulin (ATG) followed by either adalimumab or verapamil to preserve insulin secretion. Another study, NCT06037811, is a Phase 2 trial enrolling 30 patients with immune checkpoint inhibitor-associated inflammatory arthritis to assess early adalimumab induction.

Several trials focus on inflammatory bowel diseases. For Crohn's disease, a Phase 4 study (NCT07510191) with an enrollment target of 312 participants compares standard-dose TNF inhibitor plus low-dose upadacitinib against TNF inhibitor dose intensification in patients with suboptimal response. Another Phase 4 trial (NCT06180382) is recruiting 220 patients to compare vedolizumab treatment with adalimumab dose intensification for those who have lost response. Takeda is sponsoring a Phase 4 study (NCT06045754) involving 100 adults with moderate to severe Crohn's disease, investigating vedolizumab in combination with either adalimumab or ustekinumab. The PATHFINDER trial (NCT05928039) aims to determine optimal first-line biologic treatment strategies for ileal-dominant Crohn's disease, enrolling 297 participants. Additionally, the Control Crohn Safe Trial (NCT03917303) compares adalimumab to standard step-up care for 158 patients with Crohn's disease.

For ulcerative colitis, a Phase 4 study (NCT04183608) is enrolling 238 patients to compare standard of care with a treat-to-target approach using telemonitoring and patient education when initiating adalimumab. A separate Phase 4 trial (NCT05313620) with 30 participants is examining the effect of tofacitinib versus anti-TNFα drugs like adalimumab on coagulation and platelet function in ulcerative colitis.

Rheumatoid arthritis is another key area of research. A Phase 4 trial (NCT06440629) is recruiting 350 adults to compare proactive therapeutic drug monitoring with standard of care for patients on subcutaneous TNF inhibitors. Another Phase 4 study (NCT06527534) with 30 participants compares filgotinib and adalimumab effects on proteomic and micro-RNA profiles. A large Phase 4 study (NCT05626348) is observing the clinical efficacy of immunomodulators, including adalimumab plus methotrexate, in 400 rheumatoid arthritis patients. A Phase 3 trial (NCT03414502) is also seeking 400 participants with rheumatoid arthritis to identify predictors of response to various DMARDs, including adalimumab.

Studies are also underway for less common conditions. An open-label Phase 2 study (NCT06941376) is evaluating the effectiveness of immunomodulatory medications, including adalimumab, for 20 patients with relapsing polychondritis. For Takayasu arteritis, a Phase 4 trial (NCT06498089) is comparing precision treatment with conventional regimens in 124 patients, and a pilot Phase 4 study (NCT04300686) with 40 participants compares tocilizumab and adalimumab in severe cases. A study (NCT07491913) is also exploring biologic treatment withdrawal in 40 Takayasu arteritis patients in sustained remission. For Vogt-Koyanagi-Harada disease, a study (NCT05590416) is investigating adalimumab in 15 patients with acute disease.

Other recruiting trials include: a Phase 3 study (NCT06100744) comparing risankizumab and adalimumab in 40 children with juvenile psoriatic arthritis; a Phase 2 study (NCT06062875) for 70 participants with benign prostatic hyperplasia/LUTS evaluating adalimumab versus placebo; a Phase 2 trial (NCT05590455) assessing adalimumab's impact on 3-month mortality in 130 HIV-1 infected patients with tuberculosis meningitis; and a Phase 2 study (NCT02706704) comparing intravitreal versus subcutaneous adalimumab in 32 patients with non-infectious uveitis.

Furthermore, several studies are focused on understanding adalimumab's properties or broader disease management. This includes a Phase 1 study (NCT07181694) with 444 healthy adult males to establish pharmacokinetic comparability and safety of BCD-057 biosimilars against Humira 100 mg/mL. A Phase 2 study (NCT03938701) is using fluorescence imaging with adalimumab-800CW in 36 IBD and rheumatoid arthritis patients. A Phase 2/3 study (NCT05535738) with 45 participants is using a contact dermatitis model to study skin inflammation and anti-inflammatory therapies. Registries like NCT05503875 for psoriasis immunoclassification (100 participants), NCT04725422 for chronic nonbacterial osteomyelitis (2000 participants), and NCT01706692 for psoriasis and psoriatic arthritis (1121 participants) are also collecting long-term data on patients receiving various treatments, including adalimumab. Finally, a Phase 4 study (NCT04646187) with 148 participants is investigating the de-escalation of anti-TNF therapy in inflammatory bowel disease.

Where to Participate

Clinical trials involving adalimumab are currently recruiting participants across a wide geographical area, spanning 68 sites in 62 cities across 29 states. This broad reach ensures diverse representation and accessibility for many patients.

Top recruiting locations include:

• Houston, Texas
• Indianapolis, Indiana
• Glenview, Illinois
• Tampa, Florida
• Seattle, Washington
• Minneapolis, Minnesota
• San Antonio, Texas
• San Francisco, California
• Newport Beach, California
• Little Rock, Arkansas

Eligibility for these trials is generally inclusive, welcoming participants of all genders, ranging in age from 5 to 100 years. Many studies also include children, and some specifically seek healthy volunteers to help understand the drug's basic properties.

Development Timeline

The journey of adalimumab in clinical research began on November 5, 2002, marking the start of an extensive development program. Since then, a total of 463 trials have been initiated, involving a remarkable 134,928 participants.

Early development was primarily driven by Abbott and later by AbbVie, with these two sponsors collectively leading a significant portion of the research. Over time, a diverse group of other sponsors, including Pfizer, Eli Lilly and Company, and numerous academic institutions, joined the effort, reflecting the widespread interest in adalimumab's therapeutic potential.

The clinical pipeline for adalimumab has progressed through all phases of development, with a strong emphasis on later-stage research. The majority of trials have been conducted in Phase 3 (153 trials) and Phase 4 (116 trials), focusing on confirming efficacy and safety in larger populations and real-world settings. Phase 2 studies (71 trials) explored optimal dosages and initial efficacy, while Phase 1 trials (28 trials) investigated fundamental aspects like pharmacokinetics and safety in healthy volunteers.

Initially, research explored conditions such as IBS-C and hyperphosphatemia. However, the development quickly expanded to a broad spectrum of autoimmune and inflammatory diseases. Key indications like Crohn's Disease, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, and Rheumatoid Arthritis became central to the research efforts. The scope continued to widen, encompassing conditions such as Uveitis, Hidradenitis Suppurativa, and Takayasu Arteritis, demonstrating adalimumab's versatility as an anti-inflammatory agent. The latest recorded trial is set to conclude in May 2026, indicating ongoing commitment to exploring and optimizing adalimumab's role in patient care.