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Dermatitis, AtopicPhase 1/2NCT05641558

Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 1/2 study testing 611 150mg, 611 300mg and 611 600mg in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 5 sites in China.

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

The primary objective of the study was to evaluate the safety and tolerability of 611 in chinese adults with moderate to severe atopic dermatitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatitis, Atopic
What is being tested?
611 150mg, 611 300mg and 611 600mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
5 sitesChina
Study dates
18 Oct 2021to 21 Oct 2022
Phase
Phase 1/2
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

  • Male or female, 18 years or older who has AD (according to Williams Criteria) at the screening visit.
  • AD that had been present for at least 1 year before the baseline visit.
  • Body mass index (BMI) was 19-32 kg/m^2 (including boundary values), male subjects weighed ≥50.0kg, female subjects weighed ≥45.0kg.
  • Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16.
  • Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe).
  • Participants with >=10 percent (%) body surface area (BSA) of AD involvement.
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  • Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4.
  • Recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
  • Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days before the baseline visit.
  • Subject must be able to understand and complete the study related questionnaires and sign the written informed consent (ICF).

Who cannot join

  • Presence of any one of the following lab abnormalities at screening: Hemoglobin ≤ the lower limit of normal (LLN); White blood cell count below LLN; Neutrophil count below LLN; Blood platelet count below LLN; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN); Total bilirubin ≥ 1.5 × ULN; Serum creatinine (Cr) ≥ 1.5×ULN;
  • History of treatment with dupilumab, anti-interleukin (IL)-4 or IL13 agents.
  • Patients who have received any of the following treatments within 4 weeks before baseline: Treatment with immunosuppressive/immunomodulating substances (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma [IFN-γ], oral JAK inhibitors, compound glycyrrhizin, azathioprine, or methotrexate); Treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light emitting device (LED) therapy;
  • Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, phosphodiesterase (PDE) inhibitors, or Janus kinase (JAK) inhibitors within 1 weeks before baseline;
  • Treatment with systemic traditional Chinese medicine (TCM) within 4 weeks before baseline or treatment with topical TCM within 1 weeks before baseline;
  • Patients who have received any of the following biological agents: Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline. Treatment with other biological agents within 3 months before baseline or 5 drug half-lives (if known), whichever is longer;
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  • Have undergone bleaching baths ≥ twice within 2 weeks before baseline;
  • Planned or anticipated use of any banned drugs or any prohibited therapeutic procedures during the study.
  • Have been vaccinated with live (attenuated) vaccine within 8 weeks before baseline or planned during the study period or within 12 months after the study;
  • History of hypersensitivity to any biological agents. History of hypersensitivity to 611 or their excipients.
  • Participants who had donated blood (≥200 ml) within 8 weeks before enrollment or had severe blood loss of ≥200 ml, received a blood transfusion within 8 weeks, or planned to donate blood during the course of the study.
  • Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis).
  • Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
  • History of alcohol within 6 months before baseline.
  • Smoking more than 5 cigarettes per day within 3 months before the screening visit, or unable to stop using any tobacco products during the trial;
  • History of drug abuse or urine drug screening was positive.
  • Hepatitis B surface Antigen (HBsAg)-positive, or Hepatitis B core Antibody (HbcAb) was positive and Hepatitis B surface Antibody (HBsAb) was negative, or Hepatitis C Virus Antibodie (HCV Ab)-positive, Human Immunodeficiency Virus Antibody (HIV Ab) positive;
  • Presence of skin comorbidities that may interfere with study assessments.
  • History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
  • History of parasitic infections within 6 months before baseline.
  • Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study.
  • Any other medical or psychological condition that was judged by the investigator to be ineligible for enrollment.
  • Planned or anticipated major surgical procedure during the patient's participation in this study.
  • Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period. Women/men unwilling or unable to use highly effective contraception throughout the study period until at least 6 months after the last dose of study drug, and Women of Childbearing Potential (WOCBP) who had a positive pregnancy test and/or were unwilling or unable to undergo a pregnancy test
  • Other conditions were deemed by the investigator to be inappropriate for trial participation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330001

  • Nanyang First People's Hospital

    Nanyang, Henan, 473010

  • The First of Hospital China Medical University

    Shenyang, Liaoning, 110001

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective of the study was to evaluate the safety and tolerability of 611 in chinese adults with moderate to severe atopic dermatitis.

Read the detailed description

The maximum study duration was 30 weeks per participants, including a screening period of up to 2 weeks, a 4-weeks single dose treatment period, and then a 16-weeks repeated dose treatment period, and an 8-week follow-up period.

Being tested
611 150mg, 611 300mg, 611 600mg, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • 611 150mgDrug

    subcutaneous injection, 150 mg (single dose treatment period) + 300mg (loading dose, week 0) + 150mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)

  • 611 300mgDrug

    subcutaneous injection, 300 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 1 to Week 15, 8 cycles)

  • 611 600mgDrug

    subcutaneous injection, 600 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)

  • PlaceboOther

    During the study, placebos shall be filled timely according to the administration of the test drug to ensure the consistency of the times of administration in each group, so as to maintain the blind state.

Study groups in NCT05641558
Study groupRoleWhat they receive
611 dose 1 plus placeboExperimentalOne subcutaneous injections of 611 150 mg on Day 1, followed by a 4-week observation period. Two subcutaneous injections of 611 150 mg (for a total of 300 mg) as a loading dose on Week 0 Day 29, followed by one 150 mg injection quaque week (QW) from Week 1 to Week 15 (15 cycles).
Receives: Drug: 611 150mg; Other: Placebo
611 dose 2 plus placeboExperimentalTwo subcutaneous injections of 611 150 mg (for a total of 300 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection quaque 2 week (Q2W) from Week 1 to Week 15 (8 cycles).
Receives: Drug: 611 300mg; Other: Placebo
611 dose 3 plus placeboExperimentalFour subcutaneous injections of 611 150 mg (for a total of 600 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection QW from Week 1 to Week 15 (15 cycles).
Receives: Drug: 611 600mg; Other: Placebo

What is being measured

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

  1. Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.

    The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

    Measured: Up to 24 Weeks (Day 197).

Secondary outcomes (16)

  1. Maximum Concentration (Cmax).

    Maximum Observed Serum Concentration (Cmax) of 611

    Measured: Baseline to Week 24 (Day 197).

  2. Minimum concentration (Cmin).

    Minimum concentration (Cmin) of 611.

    Measured: Baseline to Week 24 (Day 197).

  3. Time to Reach the Maximum Concentration (Tmax).

    Time to Reach the Maximum Serum Concentration (Tmax) of 611.

    Measured: Baseline to Week 24 (Day 197).

  4. Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last).

    Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last) of 611.

    Measured: Baseline to Week 24 (Day 197).

  5. AUC to the end of the dosing period (AUC0-tau)

    AUC to the end of the dosing period (AUC0-tau) of 611.

    Measured: Baseline to Week 24 (Day 197).

  6. Clearance rate (CL/F).

    Clearance rate (CL/F) of 611.

    Measured: Baseline to Week 24 (Day 197).

  7. Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.

    Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.

    Measured: Baseline to Week 24 (Day 197).

  8. Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

    The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

  9. Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

  10. Percentage Change in EASI Score

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

  11. Percentage Change in Percent Body Surface Area (BSA) of AD Involvement.

    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.

    Measured: Baseline , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

  12. Number of Participants Who Achieved >=4 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141).

  13. Change in serum concentrations of Thymus and activation regulated chemokine (TARC)

    Change in serum concentrations of TARC

    Measured: Baseline to Week 24 (Day 197).

  14. Change in serum concentrations of immunoglobulin E (IgE)

    Change in serum concentrations of IgE.

    Measured: Baseline to Week 24 (Day 197).

  15. Change in whole blood eosinophil counts

    Change in whole blood eosinophil counts.

    Measured: Baseline to Week 24 (Day 197).

  16. Change in serum concentrations of lactate dehydrogenase (LDH)

    Change in serum concentrations of lactate dehydrogenase (LDH).

    Measured: Baseline to Week 24 (Day 197).

Timeline

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

  1. First posted7 Dec 2022
  2. Study start18 Oct 2021
  3. Primary completion21 Oct 2022
  4. Study completion21 Oct 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05641558
Sponsor's protocol ID
SSGJ-611-AD-I-C
Status last verified
Nov 2022
First submitted
2 Nov 2022
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 611 150mg, 611 300mg and 611 600mg in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 5 sites in China.

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 10 inclusion and 26 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. (time frame: Up to 24 Weeks (Day 197).). 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 NCT05641558.

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 7 Dec 2022.

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