Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Anti-Inflammatory Agents

Antirheumatic Agents

All Drugs and Chemicals

Adalimumab

Tumor Necrosis Factor Inhibitors

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.

Participants will receive subcutaneous (SC) injection of adalimumab

Participants will receive SC injection of ABP 501

ABP 501

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Participants analyzed according to actual treatment received.

Participants analyzed according to treatment received.

Time to reach maximum serum concentration.

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.

A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.

Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Amgen

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.

Period 1 (Lead-in Period)

Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Period 2 (Continued-use Group)

Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).

Period 2 (Switching Group)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data is reported for the Safety Analysis Set and reflects data collected at baseline for the switching and continued use groups.

Study Director

The Pharmacokinetic (PK) Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between Weeks 28 and 30.

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

The PK Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30.

Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of investigational product (IP) post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization.

Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Week 12

Week 16

Week 20

Week 28

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of IP post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization. All participants reported in the overall number of participants analyzed contributed data to this analysis.

Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Based on the per-protocol (PP) efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

PASI Percent Improvement From Baseline (Day 1) to Week 30

Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

Number of Participants Achieving PASI 75 Response at Week 30

Number of Participants Achieving PASI 90 Response at Week 30

Number of Participants Achieving PASI 100 Response at Week 30

TEAE

Serious TEAE

Population from the Safety Analysis Set (SAS). Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Number of Participants Experiencing Events of Interest (EOI)

Participants with a post-randomization result

Binding antibody negative or no result prior to the first dose of post-randomization IP

Binding antibody positive with negative/no result prior to first dose post-randomization

Transient binding antibody positive with negative/no result prior to first dose post-randomization

Neutralizing antibody negative or no result prior to the first dose of post-randomization IP

Neutralizing antibody positive with negative/no result prior to first dose post-randomization

Transient neutralizing antibody positive with negative/no result prior first dose post-randomization

Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization

Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.

Period 2

Neoplasms

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Immune System Diseases

Rare Diseases

Hypertrophy

Cicatrix, Hypertrophic

Cicatrix

Eczema

Keloid

Pain

Lichen Planus

Prurigo

Acne Vulgaris

Scleroderma, Localized

Neurodermatitis

Alopecia

Alopecia Areata

Cysts

Granuloma

Granuloma Annulare

Epidermal Cyst

Keratoacanthoma

Muir-Torre Syndrome

Hypotrichosis

Hair Diseases

Pathological Conditions, Anatomical

Dermatitis

Skin Diseases, Eczematous

Lichenoid Eruptions

Exanthema

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Fibrosis

Lymphoproliferative Disorders

Lymphatic Diseases

Necrobiotic Disorders

Prurigo Nodularis

Lichen Planopilaris

Frontal Fibrosing Alopecia

Morphea

Localized Scleroderma

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

This arm will include an injection mixture of corticosteroid and lidocaine

This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.

Corticosteroid with lidocaine

Corticosteroid with normal saline

Brian Drolet, MD

Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.

Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.

The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.

Pain Outcomes Following Intralesional Corticosteroid Injections

The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial

IPD will not be shared with other researchers

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Vanderbilt University Medical Center

Assistant Professor

This arm will include an injection mixture of corticosteroid and lidocaine

Corticosteroid with lidocaine: Intralesional corticosteroid injection

Corticosteroid With Lidocaine

This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.

Corticosteroid with normal saline: Intralesional corticosteroid injection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis	NCT05073315	Plaque Psoriasi...	Adalimumab ABP 501	18 Years - 75 Years	Amgen
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis	NCT05073315	Plaque Psoriasi...	Adalimumab ABP 501	18 Years - 75 Years	Amgen
Pain Outcomes Following Intralesional Corticosteroid Injections	NCT03630198	Keloid Alopecia Areata Acne Hypertrophic Sc... Epidermal Inclu... Frontal Fibrosi... Lichen Plano-Pi... Keratoacanthoma Plaque Psoriasi... Lichen Simplex ... Prurigo Nodular... Nummular Eczema Granuloma Annul... Morphea Lichen Planus	Corticosteroid ... Corticosteroid ...	12 Years -	Vanderbilt University Medical Center

Spots Global Cancer Trial Database for plaque psoriasis