A Study of CC-99677 in Participants With Active Ankylosing Spondylitis

(AS SpA axSpA Trial)

Recruiting at 137 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celgene

Must not be taking: Cell depleting biologics, Corticosteroids

Disqualifiers: Total spine ankylosis, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

167 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot be on certain treatments like cell depleting biologic agents within 6 months before starting the trial, or high doses of oral corticosteroids for more than 2 weeks before the trial.

What safety data exists for the treatment known as CC-99677, Placebo, Control, or Dummy Treatment?

The safety data for treatments like CC-99677 and placebo often lack detailed reporting in clinical trials, with many studies not specifying reasons for withdrawals due to toxicity or adequately reporting adverse effects. It's important for trials to systematically collect and analyze safety data, including adverse effects and reasons for discontinuation, to better understand the treatment's safety profile. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called CC-99677 to see if it helps people with Ankylosing Spondylitis (AS). The study will measure changes in symptoms, disease activity, and quality of life over a few months. The goal is to find out if this medication can reduce pain and inflammation, making it easier for patients to move and feel better.

Research Team

Bristol-Myers Squibb, MD

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Ankylosing spondylitis is a rheumatic disease that principally affects the spine

Spondylitis Disease Activity Score (BASDAI) of ≥4 If someone has an active axial disease at both the time of their screening and baseline visits, then their Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) must be 4 or higher in order for them to be considered to have active axial disease.

A person has spondylitis if their BASDAI score is ≥ 4 and their total back pain is ≥ 4.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-99677 or placebo to evaluate efficacy and safety in treating Ankylosing Spondylitis over a 12-week double-blind period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CC-99677
• Placebo

Participant Groups

Group I: Administration of CC-99677 60mg QD PO. Experimental Treatment 1 Intervention

20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy

Group II: Administration of CC-99677 60mg QD PO Experimental Treatment 1 Intervention

49 participants will be randomized to CC-99677 60 mg in biologic naive main study

Group III: Administration of CC-99677 150 mg QD PO. Experimental Treatment 1 Intervention

20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy

Group IV: Administration of CC-99677 150 mg QD PO Experimental Treatment 1 Intervention

49 participants will be randomized to CC-99677 150 mg in biologic naive main study

Group V: Placebo additional dose cohort Placebo Group 1 Intervention

10 participants will be randomized to placebo in biologic-failure substudy

Group VI: Administration of Placebo QD PO Placebo Group 1 Intervention

49 participants will be randomized to placebo in biologic naive main study

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

In a review of 231 randomized placebo-controlled clinical trials, it was found that a staggering 96.8% of adverse events (AEs) reported in patients taking active drugs were nonspecific, meaning they were not directly related to the medication.

The study revealed strong correlations between AE rates in placebo and active-drug groups, indicating that many reported AEs may not be caused by the drug itself, which raises concerns about the reliability of clinical trial data in assessing drug tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Mahr, A., Golmard, C., Pham, E., et al.[2022]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. [2023]