Granuloma AnnularePhase 1NCT05580042

Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients with Granuloma Annulare

A Phase 1 study testing AC-1101 in people with Granuloma Annulare, run by TWi Biotechnology, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study AC-1101-GA-001 is an early phase open-label study with a 4-week treatment and 2-week follow-up period (without treatment) to assess the safety, tolerability, and efficacy of AC-1101 gel in patients with Granuloma Annulare. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Granuloma Annulare
What is being tested?: AC-1101
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2022to 15 Nov 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18 years of age or older, male or female, will be enrolled.
Diagnosis of granuloma annulare with supportive skin biopsy (diagnostic shave biopsy or punch biopsy) or historical biopsy (a provided report would be sufficient and would not require to repeat the diagnostic biopsy). A biopsy at any point is sufficient. If a diagnostic biopsy has never been performed, one will be performed prior to enrollment in the study. Patients with both localized and generalized GA will be enrolled in the proposed study.
Other subtypes of GA, such as linear, perforating, and subcutaneous will be excluded from the study. If there is suspicion that GA is medication-induced, the patient will not be enrolled. GA in association with human immunodeficiency virus (HIV) or malignancy will be excluded.
Patients with 1-20% BSA of active Granuloma Annulare lesions will be enrolled.
Duration of active GA must be at least two years with no significant change in size or number of lesions in the 6 months prior to treatment as supported by a combination of record review and history/patient interview.
Patients who might be recalcitrant to or intolerant of conventional treatment, such as antibiotics (e.g., doxycycline or minocycline), triple antibiotic therapy of rifampin, ofloxacin, and minocycline, topical corticosteroids, topical calcineurin inhibitors, intralesional/intramuscular corticosteroid and/or phototherapy.

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Adequate organ function and marrow function meaured at screening (Visit 1) and enrollment (Visit 2) as defined below:
Hemoglobin ≥ 12.0 g/dL for male and 10.5 g/dL for female;
Absolute neutrophil count ≥ 1,300 /µL;
Absolute lymphocytes: 1.0-4.0 x 109/L (1000-4000 cells/mm3) as the reference range;
Platelets ≥ 75,000/µL;
Total bilirubin ≤ 1.5 x upper normal limit;
AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit;
eGFR ≥ 60mL/min/1.73m2
Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration.
Intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to study drug administration.
Male partner using condom with intravaginally applied spermicide started at least 21 days prior to study drug administration.
Sterile male partner (vasectomized since at least 6 months).
Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, bilateral tubal occlusion, sexual abstinence (when this is in line with preferred and usual lifestyle). No combined hormonal contraceptive methods (such as most oral pills, rings or patches) are permitted.
Capable of consent: Able to read, understand, and sign the Informed Consent Form (ICF), answer the study questionnaires, communicate with the Investigator, and understand and comply with protocol requirements.
Patients must speak English.
Patients must have health insurance.

Who cannot join

Patients with active malignancy will not be permitted to enroll in the proposed study. Patients with a history of treated nonmelanoma skin cancer will be eligible to enroll.
Patients under treatment with biologics or other systemic immunosuppressive medications (e.g., methotrexate (MTX), mycophenolate) within the last 3 months.
Presence of any clinically significant abnormality at physical examination, clinically significant abnormal laboratory assessment or positive test for hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), or HIV found during medical screening.
History of allergic reactions to tofacitinib or other related drugs, or to any excipient in the formulation.
Positive pregnancy test at screening. If a woman becomes pregnant during the study, she will stop the study medication and be removed from the study. She will be urged to follow up with her Primary Care Physician or obstetrician-gynecologist. The study doctors will ask to follow the pregnancy to its outcome.
Women of childbearing potential who are unable or unwilling to use birth control (oral pills, rings or patches are not permitted) while taking the medication.

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Pregnant or breast-feeding women.
Current active smokers.
Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving drug or device administration.
History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
Positive QuantiFERON®-TB indicating possible tuberculosis infection.
Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study.
History of clinically significant opportunistic infection, e.g., invasive fungal infections or pneumocystis pneumonia.
Serious local infection, e.g., cellulitis, abscess, or systemic infection, e.g., septicemia, within 3 months prior to screening.
Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis, such as Acetaminophen (2g in 24-hour period) because they are judged unlikely to affect the PK profile of the study drug or subject safety:
Prescription medications within 14 days prior to the first dosing with the exception of on-going medications to treat existing comorbid disorders, as judged by the Investigator.
Topical medications inlcuding antibiotics or corticosteriod applied to the designated treatment area.
Depot injection or implant of any drug within 3 months prior to the first dosing.
Any drugs known to significantly induce or inhibit hepatic drug metabolism via the CYP3A4 and CYP2C19 enzymes within 30 days prior to first dosing.
Fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
Subjects with a personal history of significant coronary heart disease, heart failure, and/or cerebrovascular disease.
Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Center for Clinical Investigation
New Haven, Connecticut, 06519

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About this study

Official title: An Open-Label, Single Arm, Phase I Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients with Granuloma Annulare

Conditions: Granuloma Annulare
Being tested: AC-1101
Keywords: Tofacitinib Topical Gel 2%, AC-1101 gel
Medical subject headings: Granuloma Annulare

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AC-1101Drug
Also called Tofacitinib Topical Gel 2%, AC-1101 gel
For each patient, once daily (QD)

Study groups in NCT05580042
Study group	Role	What they receive
Patients with Granuloma Annulare	Experimental	4-week treatment and 2-week follow-up period (without treatment) Receives: Drug: AC-1101

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and proportion of subjects with treatment emergent adverse events (TEAEs), AEs and serious adverse events (SAEs).
Adverse events (AEs), Significant Adverse Events (SAEs), treatment emergent adverse events (TEAEs)
Measured: Up to 6 weeks
Number of subjects with abnormal vital signs
Vital sign parameters will be analyzed including oral temperature, pulse rate, respiratory rate, and blood pressure.
Measured: Up to 6 weeks
Number of subjects with abnormal ECG
ECGs will be obtained by using an automated ECG machine to measure PR, QRS, QT, and QTc intervals and calculates heart rate.
Measured: Up to 6 weeks
Number of subjects with abnormal hematology parameters
Hematology parameters will be analyzed including platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, percent reticulocytes, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Measured: Up to 6 weeks
Number of subjects with abnormal biochemistry parameters
Biochemistry parameters will be analyzed including blood urea nitrogen (BUN), creatinine, glucose, phosphorus, calcium, phosphate, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, creatine phosphokinase (CPK), total bilirubin, direct bilirubin, total protein, albumin to gloulin ratio, globulin, lipase, and Hemoglobin A1C..
Measured: Up to 6 weeks
Number of subjects with abnormal urinalysis parameters
Urinalysis parameters will be analyzed including specific gravity, urine creatinine, phosphate and pregnancy test..
Measured: Up to 6 weeks
Change in skin irritation using Dermal Rating Scale (DRS)
This is a 0-4 rating with 0 representing the best.
Measured: Up to 4 weeks

Secondary outcomes (6)

Plasma concentration of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC[0-t]) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUC[0-infinity]) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Maximum observed plasma drug concentration (Cmax) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Apparent terminal half-life (T1/2) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Measured: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202215 Nov 2023

First posted14 Oct 2022
Study start3 Oct 2022
Primary completion15 Nov 2023
Study completion15 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Granuloma AnnulareStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: patients with Granuloma Annulare
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05580042
Sponsor's protocol ID: AC-1101-GA-001
Status last verified: Oct 2024
First submitted: 2 Oct 2022
Last updated: 15 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single Arm, Phase I Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients with Granuloma Annulare
ClinicalTrials.gov ID: NCT05580042
Acronym / sponsor ID: AC-1101-GA-001
Conditions: Granuloma Annulare
Keywords: Tofacitinib Topical Gel 2%, AC-1101 gel
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: TWi Biotechnology, Inc.Industry (pharma, biotech, devices)
Study start: 3 Oct 2022 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 15 Nov 2023 (actual)
First posted: 14 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: patients with Granuloma Annulare

Arm	Type	Receives
Patients with Granuloma Annulare	Experimental	Drug: AC-11014-week treatment and 2-week follow-up period (without treatment)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Patients 18 years of age or older, male or female, will be enrolled.
Diagnosis of granuloma annulare with supportive skin biopsy (diagnostic shave biopsy or punch biopsy) or historical biopsy (a provided report would be sufficient and would not require to repeat the diagnostic biopsy). A biopsy at any point is sufficient. If a diagnostic biopsy has never been performed, one will be performed prior to enrollment in the study. Patients with both localized and generalized GA will be enrolled in the proposed study.
Other subtypes of GA, such as linear, perforating, and subcutaneous will be excluded from the study. If there is suspicion that GA is medication-induced, the patient will not be enrolled. GA in association with human immunodeficiency virus (HIV) or malignancy will be excluded.
Patients with 1-20% BSA of active Granuloma Annulare lesions will be enrolled.
Duration of active GA must be at least two years with no significant change in size or number of lesions in the 6 months prior to treatment as supported by a combination of record review and history/patient interview.

Key exclusion criteria (22 listed)

Patients with active malignancy will not be permitted to enroll in the proposed study. Patients with a history of treated nonmelanoma skin cancer will be eligible to enroll.
Patients under treatment with biologics or other systemic immunosuppressive medications (e.g., methotrexate (MTX), mycophenolate) within the last 3 months.
Presence of any clinically significant abnormality at physical examination, clinically significant abnormal laboratory assessment or positive test for hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), or HIV found during medical screening.
History of allergic reactions to tofacitinib or other related drugs, or to any excipient in the formulation.
Positive pregnancy test at screening. If a woman becomes pregnant during the study, she will stop the study medication and be removed from the study. She will be urged to follow up with her Primary Care Physician or obstetrician-gynecologist. The study doctors will ask to follow the pregnancy to its outcome.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AC-1101Also: Tofacitinib Topical Gel 2%, AC-1101 gelFor each patient, once daily (QD)	Drug	Patients with Granuloma Annulare

Primary outcome

Incidence and proportion of subjects with treatment emergent adverse events (TEAEs), AEs and serious adverse events (SAEs).
Time frame: Up to 6 weeks
Adverse events (AEs), Significant Adverse Events (SAEs), treatment emergent adverse events (TEAEs)
Number of subjects with abnormal vital signs
Time frame: Up to 6 weeks
Vital sign parameters will be analyzed including oral temperature, pulse rate, respiratory rate, and blood pressure.
Number of subjects with abnormal ECG
Time frame: Up to 6 weeks
ECGs will be obtained by using an automated ECG machine to measure PR, QRS, QT, and QTc intervals and calculates heart rate.
Number of subjects with abnormal hematology parameters
Time frame: Up to 6 weeks
Hematology parameters will be analyzed including platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, percent reticulocytes, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Number of subjects with abnormal biochemistry parameters
Time frame: Up to 6 weeks
Biochemistry parameters will be analyzed including blood urea nitrogen (BUN), creatinine, glucose, phosphorus, calcium, phosphate, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, creatine phosphokinase (CPK), total bilirubin, direct bilirubin, total protein, albumin to gloulin ratio, globulin, lipase, and Hemoglobin A1C..
Number of subjects with abnormal urinalysis parameters
Time frame: Up to 6 weeks
Urinalysis parameters will be analyzed including specific gravity, urine creatinine, phosphate and pregnancy test..
Change in skin irritation using Dermal Rating Scale (DRS)
Time frame: Up to 4 weeks
This is a 0-4 rating with 0 representing the best.

6 secondary outcomes

Plasma concentration of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC[0-t]) of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUC[0-infinity]) of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Maximum observed plasma drug concentration (Cmax) of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax) of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Apparent terminal half-life (T1/2) of AC-1101
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Damsky, M.D., Ph.D. principal investigator

Yale Department of Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AC-1101 in people with Granuloma Annulare, run by TWi Biotechnology, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and proportion of subjects with treatment emergent adverse events (TEAEs), AEs and serious adverse events (SAEs). (time frame: Up to 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.